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NCT Number: NCT07417254

Novel Personalised Nutrition Intervention With Tailored Behavioural Support

The aim of this study is to test the efficacy of a novel personalised nutrition intervention with tailored behavioural support compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in young (18-30 years), healthy university students.

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Key information

Conditions

Behavior Change Behavior And Behavior Mechanism Behavior Change Interventions Dietary Behaviour Personalised Nutrition Sustainable Healthy Diet

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin, Belfield

Dublin, Dublin 4, Ireland

About this study

Recruitment:

Participants will be recruited from the University College Dublin (UCD) PLAN'EAT Living Lab (LL) Citizen Panel (https://clinicaltrials.gov/study/NCT06939231), as well as from the wider eligible UCD university population. Eligible participants will be invited to participate in a 4-week study.

Power analysis:

The trial was powered for the group main effect in an analysis of covariance (ANCOVA) of the endpoint primary outcome variable adjusted for the baseline value of the primary outcome variable. Using G*Power 3.1 (F tests → ANCOVA: fixed effects, main effects and interactions), we set α = 0.05, power = 0.80, numerator df = 1, number of groups = 2, and number of covariates = 1. The effect size was taken from the primary outcome of the pilot trial (legume intake, g/d): partial eta squared (η²p) = 0.134, converted to Cohen's f, using the formula:

f = √η²p/(1- η²p)

where η²p = 0.134, resulting in a Cohen's f of 0.393. The power calculation indicated an estimated required total sample size of 53 participants. Allowing for 20% attrition (pilot trial attrition rate: 17%), the estimated required total sample size increased to 66 participants (n=33 per group). Pilot trial registration: https://clinicaltrials.gov/study/NCT06631469.

Randomisation:

After completion of successful screening and informed consent, participants will be randomised in a 1:1 ratio to either the control or intervention group using block randomisation stratified by sex, using randomly permuted blocks of size four within each sex group to maintain equal allocation (using the blockrand package in R). This randomisation method was chosen as it resulted in a balanced distribution of demographics and baseline dietary intake data across intervention and control groups in the pilot trial.

Intervention overview:

Each group will receive different types of personalised nutrition interventions using decision tree algorithms to support them to consume a healthier and more sustainable diet. The control group will receive a personalised dietary plan and standardised behavioural support (based on the standardised support provided in the pilot trial, which was based on previous personalised nutrition trials and usual care in dietetic practice) to meet their personalised dietary recommendations. The intervention group will receive the same intervention as the control group, with additional tailored behavioural support to help them meet their personalised dietary recommendations.

Baseline:

Participants will be asked to attend a study visit at the UCD Institute of Food and Health where they will complete baseline questionnaires (i.e., consent form, demographics, health, lifestyle, medical history, medication use, supplement use, dietary behaviour questions) and a study nutritionist-guided 24-hour dietary recall via the web-based tool, Foodbook24. Upon giving consent, the participant will also be provided with two urine collection kits (one for study baseline and endpoint) and instructed to collect their urine first thing in the morning (i.e., first-void) and bring it with them on the day of their second baseline in-person visit at the UCD Institute of Food and Health. The participant will be asked to self-complete two further dietary recalls on non-consecutive days before attending the second in-person visit (for a total of three); however, participants will be allowed to attend the second in-person visit in the case that only two 24-hour dietary recalls are completed (in total).

During the second baseline in-person visit at the UCD Institute of Food and Health, a member of the research team will measure participant anthropometrics and blood pressure, while a trained nurse will take a blood sample (if consent is given). Thereafter, the study nutritionist will deliver the intervention to participants via a diet counselling session. During this session, the study nutritionist will communicate the personalised dietary recommendations developed for the participant, providing information and support on how to achieve their recommendations, along with a resource booklet with supporting information and materials (e.g., recipes, shopping lists, etc.), while asking the participant to sign a behavioural contract, where they affirm their commitment to achieving their dietary recommendations throughout the 4-week study period. Participants will be provided with a maximum of three dietary recommendations in total, which can be any combination of the following: 1) increase legume intakes; 2) increase fruit and vegetable intakes; 3) decrease meat intakes; and 4) decrease sweet/savoury discretionary food intakes.

In addition to the above, participants in the intervention group will receive tailored behavioural support to further help them to achieve their personalised dietary recommendations. The tailored behavioural supports will be developed to overcome participants' main barriers to achieving their specific dietary recommendations towards a sustainable and healthy diet. The specific tailored interventions for participants may include: provision of foods, cooking demonstration videos, habit-building support, motivation-building support, advice to seek social support, or additional knowledge provision (depending on the participant's main barriers). The main barriers to achieving specific dietary recommendations towards a sustainable and healthy diet were identified through quantitative and qualitative data collection in young (18-30 years), healthy UCD students, as part of work conducted within the PLAN'EAT Project and the UCD PLAN'EAT Living Lab (https://clinicaltrials.gov/study/NCT06939231).

Midpoint:

All participants will be contacted by their study nutritionist via email or phone call or message at the midpoint of the study (2 weeks) to check-in on their progression and to address any queries they may have.

Endpoint:

At the end of the 4-week study, participants will complete an online diet-related questionnaire and will be asked to self-complete two 24-hour dietary recalls (via the web-based tool, Foodbook24) on non-consecutive days before attending the final in-person visit at the UCD Institute of Food and Health. However, participants will be allowed to attend the final visit in the case that only one 24-hour dietary recall is completed prior to the visit. The participant will again be instructed to collect their urine first thing in the morning (i.e., first-void) and bring it with them on the day of the final in-person visit. During the final visit, a member of the research team will re-measure participant anthropometrics and blood pressure, while a trained nurse will take a blood sample (if consent is given). Finally, the participant will complete their final study nutritionist-guided 24-hour dietary recall (via the web-based tool, Foodbook24) before leaving.

Statistical analysis plan:

Continuous outcomes will be analysed using ANCOVA (with robust (Huber-White sandwich) standard errors if model residuals are non-normal and/or heteroskedasticity is present) on an intention-to-treat principle, including the baseline variable as a covariate, via the full information maximum likelihood (FIML) method, which treats missing endpoint data as missing at random (MAR). If residual distributions deviate markedly from normality, variables will be transformed prior to use in ANCOVA. Where a group x baseline covariate interaction is detected, treatment effects will be estimated at the mean value, the mean + 1 SD value, and the mean - 1 SD value of the baseline covariate.

Sensitivity analyses for both primary and secondary estimands will be conducted per protocol, with complete cases only (i.e., ≥2 24-hour dietary recalls at endpoint), which treats missing endpoint data as missing completely at random (MCAR). Data will be analysed using ANCOVA (with robust (Huber-White sandwich) standard errors if model residuals are non-normal and/or heteroskedasticity is present) or with robust regression (via M-estimation, Huber method) if residual distributions deviate markedly from normality, including the baseline variable as a covariate. Additional sensitivity analyses for both primary and secondary estimands will be performed excluding suspected dietary under-reporters.

Exploratory analyses for continuous primary and secondary outcome measures will be conducted using linear mixed models (LMMs) across three timepoints (baseline, endpoint (4 weeks), and follow-up (8 weeks)), with fixed effects for group, time, and their interaction, and a random intercept for participants to account for within-subject correlation. The time x group interaction at follow-up (8 weeks) will be the exploratory estimand of interest for the outcome measures, and between-group post-hoc tests will be conducted where a time x group interaction is significant. Models will be estimated using Restricted Maximum Likelihood (REML) under an MAR assumption. Robust (Huber-White sandwich) standard errors will be used if model residuals are non-normal and/or heteroskedasticity is present. If residual distributions deviate markedly from normality, outcomes will be transformed prior to analysis. A per-protocol sensitivity analysis will be performed using only complete cases, which assumes missingness is MCAR. An additional sensitivity analysis will be performed excluding suspected dietary under-reporters. These data will be analysed using the same LMM specification.

Categorical/ordinal outcomes will be analysed using a cumulative link model (CLM) with a logit link, including the baseline variable as a covariate. If model convergence issues arise (e.g., due to sparse outcome categories or separation), a cumulative link mixed model (CLMM) will be fitted instead, including a random intercept for participant ID and a fixed time x group interaction to assess differential change over time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be a UCD student attending Belfield Campus.
  • Be an adult between the age of 18-30 years old, and in good general health.

Exclusion criteria

  • Do not attend UCD Belfield Campus.
  • Are <18 or >30 years of age.
  • Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnoses include (but are not limited to) cardiovascular disease, diabetes mellitus, cancers (within the past 5 years), etc.
  • Are pregnant, lactating or planning to become pregnant.
  • Are following a medically prescribed diet.
  • Are immunocompromised or have a suspected immunodeficiency.
  • Have a known food allergy.

Treatment and study plan

Personalised sustainable and healthy dietary recommendations with standardised and tailored behavioural support.

Behavioral

Participants will receive a personalised dietary plan, standardised behavioural support (based on the standardised support provided in the pilot trial (https://clinicaltrials.gov/study/NCT06631469), which was based on previous personalised nutrition trials and usual care in dietetic practice), and tailored behavioural support to help participants to meet their personalised dietary recommendations.

Personalised sustainable and healthy dietary recommendations with standardised behavioural support.

Behavioral

Participants will receive a personalised dietary plan and standardised behavioural support (based on the standardised support provided in the pilot trial (https://clinicaltrials.gov/study/NCT06631469), which was based on previous personalised nutrition trials and usual care in dietetic practice) to help participants to meet their personalised dietary recommendations.

Primary outcomes

  1. Legume intake (g/d)

    Time frame: 4 weeks

    Legume intake (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The primary outcome measure is endpoint legume intake (g/d).

    The primary estimand is the mean difference in legume intake (g/d) between groups at endpoint (4 weeks), adjusted for baseline legume intake (g/d).

    An exploratory analysis will be conducted to measure change in legume intake (g/d) between-groups at follow-up (8 weeks). The exploratory estimand will be the group × time interaction from a LMM at follow-up (8 weeks), and a between-group post-hoc test will be conducted where the group x time interaction is significant.

Secondary outcomes

  1. Total fruit and vegetable intake (g/d)

    Time frame: 4 weeks

    Total fruit and vegetable intake (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The secondary outcome measure is endpoint total fruit and vegetable intake (g/d).

    The secondary estimand is the mean difference in total fruit and vegetable intake (g/d) between groups at endpoint (4 weeks), adjusted for baseline total fruit and vegetable intake (g/d).

    An exploratory analysis will be conducted to measure change in total fruit and vegetable intake (g/d) between-groups at follow-up (8 weeks). The exploratory estimand will be the group × time interaction from a LMM at follow-up (8 weeks), and a between-group post-hoc test will be conducted where the group × time interaction is significant.

  2. Total meat intake (g/d)

    Time frame: 4 weeks

    Total meat intake (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The secondary outcome measure is endpoint total meat intake (g/d).

    The secondary estimand is the mean difference in total meat intake (g/d) between groups at endpoint (4 weeks), adjusted for baseline total meat intake (g/d).

    An exploratory analysis will be conducted to measure change in total meat intake (g/d) between-groups at follow-up (8 weeks). The exploratory estimand will be the group × time interaction from a LMM at follow-up (8 weeks), and a between-group post-hoc test will be conducted where the group × time interaction is significant.

  3. Total discretionary food intake (g/d)

    Time frame: 4 weeks

    Total discretionary food intake (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The secondary outcome measure is endpoint total discretionary food intake (g/d).

    The secondary estimand is the mean difference in total discretionary food intake (g/d) between groups at endpoint (4 weeks), adjusted for baseline total discretionary food intake (g/d).

    An exploratory analysis will be conducted to measure change in total discretionary food intake (g/d) between-groups at follow-up (8 weeks). The exploratory estimand will be the group × time interaction from a LMM at follow-up (8 weeks), and a between-group post-hoc test will be conducted where the group × time interaction is significant.

  4. Composite dietary behaviour index (CDBI) (z-score units)

    Time frame: 4 weeks

    CDBI (z-score units) will be calculated as the mean of participants' dietary recommendation z-values (i.e., some combination of: legume, fruit/vegetable, total meat, and/or discretionary food z-scores) at each timepoint (i.e., baseline and endpoint). Each individual food group z-score will be calculated by mean-centring intakes (in g/d) relative to the pooled baseline mean and dividing by the pooled baseline SD of that food group. Higher endpoint CDBI scores indicate greater dietary behaviour change in the direction of participants' dietary recommendations.

    The secondary outcome measure is the endpoint CDBI score (z-score units).

    The secondary estimand is the mean difference in CDBI score (z-score units) between groups at endpoint (4 weeks), adjusted for baseline CDBI score (z-score units).

    An exploratory analysis will be conducted to measure change in CDBI (z-score units) between groups at follow-up. The exploratory estimand will be the LMM group x time interaction at 8 weeks f/u.

Other outcomes

  1. Capability

    Time frame: 4 weeks

    Individual's self-reported capability (COM-B model component) will be calculated at baseline and endpoint based via Likert scale responses, recoded as 1-5 (i.e., from strongly disagree to strongly agree), to statements reflecting individuals' capability to achieve the dietary behavioural outcomes of interest in the current study (i.e., the primary and secondary food group outcomes).

    The tertiary outcome measure is the endpoint capability score.

    The tertiary estimand is the difference in capability score at endpoint (4 weeks), adjusted for baseline capability scores.

  2. Opportunity

    Time frame: 4 weeks

    Individual's self-reported opportunity (COM-B model component) will be calculated at baseline and endpoint based via Likert scale responses, recoded as 1-5 (i.e., from strongly disagree to strongly agree), to statements reflecting individuals' opportunity to achieve the dietary behavioural outcomes of interest in the current study (i.e., the primary and secondary food group outcomes).

    The tertiary outcome measure is the endpoint opportunity score.

    The tertiary estimand is the difference in opportunity score at endpoint (4 weeks), adjusted for baseline opportunity scores.

  3. Motivation

    Time frame: 4 weeks

    Individual's self-reported motivation (COM-B model component) will be calculated at baseline and endpoint based via Likert scale responses, recoded as 1-5 (i.e., from strongly disagree to strongly agree), to statements reflecting individuals' motivation to achieve the dietary behavioural outcomes of interest in the current study (i.e., the primary and secondary food group outcomes).

    The tertiary outcome measure is the endpoint motivation score.

    The tertiary estimand is the difference in motivation score at endpoint (4 weeks), adjusted for baseline motivation scores.

  4. Diet-related greenhouse gas emissions (kg CO2-eq/d)

    Time frame: 4 weeks

    Diet-related greenhouse gas emissions (kg CO2-eq/d) will be calculated as the sum of participants' mean daily food-related greenhouse gas emissions per food product consumed (estimated via mean dietary intake across multiple days, using multiple non-consecutive 24-hour dietary recalls via the Foodbook24 software) at baseline and endpoint.

    The tertiary outcome measure is endpoint diet-related greenhouse gas emissions (kg CO2-eq/d).

    The tertiary estimand is the mean difference in endpoint diet-related greenhouse gas emissions (kg CO2-eq/d) between groups at endpoint (4 weeks), adjusted for baseline diet-related greenhouse gas emissions (kg CO2-eq/d).

  5. Diet-related water footprint (L/d)

    Time frame: 4 weeks

    Diet-related water footprint (L/d) will be calculated as the sum of participants' mean daily food-related water footprint per food product consumed (estimated via mean dietary intake across multiple days, using multiple non-consecutive 24-hour dietary recalls via the Foodbook24 software) at baseline and endpoint.

    The tertiary outcome measure is endpoint diet-related water footprint (L/d).

    The tertiary estimand is the mean difference in endpoint diet-related water footprint (L/d) between groups at endpoint (4 weeks), adjusted for baseline diet-related water footprint (L/d).

  6. Other food group intakes (g/d)

    Time frame: 4 weeks

    Other food group intakes (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The tertiary outcome measure is endpoint other food group intakes (g/d).

    The tertiary estimand is the mean difference in other food group intakes (g/d) between groups at endpoint (4 weeks), adjusted for baseline other food group intakes (g/d).

  7. Planetary Health Diet adherence

    Time frame: 4 weeks

    Diet quality will be measured via adherence to the energy-adjusted Healthy Reference Diet (HRDea) score-a validated dietary index to assess adherence to the Planetary Health Diet. This index is calculated using food group and nutrient intakes, with a score ranging from 0-140, with higher scores indicating greater adherence to the Planetary Health Diet. The HRDea score will be calculated at baseline and endpoint.

    The tertiary outcome measure is endpoint HRDea score.

    The tertiary estimand is the mean difference in HRDea score between groups at endpoint (4 weeks), adjusted for baseline HRDea score.

  8. Energy intake (kcal/d)

    Time frame: 4 weeks

    Energy intake (kcal/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The tertiary outcome measure is endpoint energy intake (kcal/d).

    The tertiary estimand is the mean difference in energy intake (kcal/d) between groups at endpoint (4 weeks), adjusted for baseline energy intake (kcal/d).

  9. Macronutrient intakes (g/d, g/kg/d, % kcal/d)

    Time frame: 4 weeks

    Macronutrient intakes (g/d, g/kg/d, % kcal/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The tertiary outcome measures are endpoint macronutrient intakes (g/d, g/kg/d, % kcal/d).

    The tertiary estimands are the mean differences in macronutrient intakes (g/d, g/kg/d, % kcal/d) between groups at endpoint (4 weeks), adjusted for baseline macronutrient intakes (g/d, g/kg/d, % kcal/d).

  10. Micronutrient intakes (mg/d, µg/d)

    Time frame: 4 weeks

    Micronutrient intakes (mg/d, µg/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If <2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol).

    The tertiary outcome measures are endpoint micronutrient intakes (mg/d, µg/d).

    The tertiary estimands are the mean differences in micronutrient intakes (mg/d, µg/d) between groups at endpoint (4 weeks), adjusted for baseline micronutrient intakes (mg/d, µg/d).

  11. Body weight (kg)

    Time frame: 4 weeks

    Body weight (kg) will be measured using a body composition analyser (DC430MA; Tanita) at baseline and endpoint. Measurements at each timepoint will be conducted twice, with the average measurement representing the outcome value. Note: the two values to be averaged must be within <=0.1 kg of each other. Values not within limits of agreement will be discarded and measurements will be repeated until 2 valid values are obtained.

    The tertiary outcome measure is endpoint body weight (kg).

    The tertiary estimand is the mean difference in body weight (kg) between groups at endpoint (4 weeks), adjusted for baseline body weight (kg).

  12. Body mass index (kg/m2)

    Time frame: 4 weeks

    Body mass index (kg/m2) will be computed from measured height (cm) and body weight (kg). Height (cm) and body weight (kg) will be measured using a Leicester stadiometer (Seca) and body composition analyser (DC430MA; Tanita), respectively, at baseline and endpoint. Measurements at each timepoint will be conducted twice, with the average measurement representing the outcome value. Note: the two values to be averaged must be within the following limits of agreement: <=0.1 kg for body weight; <=3 mm for height. Values not within limits of agreement will be discarded and measurements will be repeated until 2 valid values are obtained.

    The tertiary outcome measure is endpoint body mass index (kg/m2).

    The tertiary estimand is the mean difference body mass index (kg/m2) between groups at endpoint (4 weeks), adjusted for baseline body mass index (kg/m2).

  13. Waist circumference (cm)

    Time frame: 4 weeks

    Waist circumference (cm) will be measured using an inelastic measuring tape (Seca) at baseline and endpoint. Measurement will be conducted twice, with the average measurement representing the outcome value. Note: the two values to be averaged must be within the following limits of agreement: <=1 cm for waist circumference. Values not within limits of agreement will be discarded and measurements will be repeated until 2 valid values are obtained.

    The tertiary outcome measure is endpoint waist circumference (cm).

    The tertiary estimand is the mean difference in waist circumference (cm) between groups at endpoint (4 weeks), adjusted for baseline waist circumference (cm).

  14. Waist-to-hip ratio

    Time frame: 4 weeks

    Waist-to-hip ratio will be calculated from measured waist (cm) and hip circumference (cm) measures. Waist (cm) and hip circumference (cm) will be measured using an inelastic measuring tape (Seca). Measurements will be conducted twice, with the average measurement representing the outcome value. Note: the two values to be averaged must be within the following limits of agreement: <=1 cm for waist circumference; <=2 cm for hip circumference. Values not within limits of agreement will be discarded and measurements will be repeated until 2 valid values are obtained.

    The tertiary outcome measure is endpoint waist-to-hip ratio.

    The tertiary estimand is the mean difference in waist-to-hip ratio between groups at endpoint (4 weeks), adjusted for baseline waist-to-hip ratio.

  15. Waist-to-height ratio

    Time frame: 4 weeks

    Waist-to-height ratio will be calculated from measured waist circumference (cm) and height (cm) measures. Waist circumference (cm) will be measured using an inelastic measuring tape (Seca). Height will be measured using a Leicester stadiometer (Seca). Measurements will be conducted twice, with the average measurement representing the outcome value. Note: the two values to be averaged must be within the following limits of agreement: <=1 cm for waist circumference; <=3 mm for height. Values not within limits of agreement will be discarded and measurements will be repeated until 2 valid values are obtained.

    The tertiary outcome measure is endpoint waist-to-height ratio.

    The tertiary estimand is the mean difference in waist-to-height ratio between groups at endpoint (4 weeks), adjusted for baseline waist-to-height ratio.

  16. Blood pressure (mmHg)

    Time frame: 4 weeks

    Blood pressure (mmHg) will be measured after five minutes in a seated position, using an Omron M6 Comfort digital sphygmomanometer (Omron Healthcare Co. Ltd., Japan), at baseline and endpoint, with the mean of >=2 measurements used as the outcome value.

    The tertiary outcome measure is endpoint blood pressure (mmHg).

    The tertiary estimand is the mean difference in blood pressure (mmHg) between groups at endpoint (4 weeks), adjusted for baseline blood pressure (mmHg).

  17. Total cholesterol (mmol/L)

    Time frame: 4 weeks

    Total cholesterol (mmol/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint total cholesterol (mmol/L).

    The tertiary estimand is the mean difference in total cholesterol (mmol/L) between groups at endpoint (4 weeks), adjusted for baseline total cholesterol (mmol/L).

  18. Low-density lipoprotein (LDL) cholesterol (mmol/L)

    Time frame: 4 weeks

    Low-density lipoprotein (LDL) cholesterol (mmol/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint LDL cholesterol (mmol/L).

    The tertiary estimand is the mean difference in LDL cholesterol (mmol/L) between groups at endpoint (4 weeks), adjusted for baseline LDL cholesterol (mmol/L).

  19. High-density lipoprotein (HDL) cholesterol (mmol/L)

    Time frame: 4 weeks

    High-density lipoprotein (HDL) cholesterol (mmol/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint HDL cholesterol (mmol/L).

    The tertiary estimand is the mean difference in HDL cholesterol (mmol/L) between groups at endpoint (4 weeks), adjusted for baseline HDL cholesterol (mmol/L).

  20. Non-high-density lipoprotein (HDL) cholesterol (mmol/L)

    Time frame: 4 weeks

    Non-high-density lipoprotein (HDL) cholesterol (mmol/L) will be calculated as total cholesterol (mmol/L) - HDL cholesterol (mmol/L). Total cholesterol (mmol/L) and HDL cholesterol (mmol/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint non-HDL cholesterol (mmol/L).

    The tertiary estimand is the mean difference in non-HDL cholesterol (mmol/L) between groups at endpoint (4 weeks), adjusted for baseline non-HDL cholesterol (mmol/L).

  21. Triglycerides (mmol/L)

    Time frame: 4 weeks

    Triglycerides (mmol/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint triglycerides (mmol/L).

    The tertiary estimand is the mean difference in triglycerides (mmol/L) between groups at endpoint (4 weeks), adjusted for baseline triglycerides (mmol/L).

  22. C-reactive protein (CRP) (mg/L)

    Time frame: 4 weeks

    C-reactive protein (CRP) (mg/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint CRP (mg/L).

    The tertiary estimand is the mean difference in CRP (mg/L) between groups at endpoint (4 weeks), adjusted for baseline CRP (mg/L).

  23. Ferritin (μg/L)

    Time frame: 4 weeks

    Ferritin (μg/L) will be measured from serum samples according to standardised clinical procedures at baseline and endpoint.

    The tertiary outcome measure is endpoint ferritin (μg/L).

    The tertiary estimand is the mean difference in ferritin (μg/L) between groups at endpoint (4 weeks), adjusted for baseline ferritin (μg/L).

  24. Urinary biomarkers of food intake

    Time frame: 4 weeks

    Biomarkers of food intake will be measured from urine samples at baseline and endpoint using liquid chromatography-mass spectrometry (LC/MS) to characterise metabolomic profiles related to the dietary exposures of interest.

    These biomarkers are exploratory outcomes; thus, no pre-defined assay or analysis plan is reported.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • PLAN'EAT Consortium (https://planeat-project.eu/)

Registry information

Official study title

A Novel Personalised NUtrition Intervention With Tailored Behavioural Support to Promote Sustainable and Healthy Diets in University Students: the P-NUTS Randomised Controlled Trial

Acronym: P-NUTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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