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Completed

NCT Number: NCT04816955

Dietary Recommendations for Reducing Free Sugar Intakes

This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bournemouth University

Bournemouth, US and Canada Only, BH12 5BB, United Kingdom

About this study

The primary objective of this randomised control trial is to assess the impacts of Public Health England's (PHE) current free sugar reducing advice, for reducing total energy intakes (TEI) of free sugar. A total of 240 participants (age 18-65years) consuming diets >5% total energy intake from dietary free sugars will be recruited from across the Dorset region. Participants to be randomly assigned into the following recommendation interventions groups: 1) Reduce free sugar intake to <5% TEI (nutrient-based recommendations); 2) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars (nutrient- + food-based recommendations); 3) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars and replace/swap with low sugar versions (nutrient- + food-based recommendations with swaps); and 4) Control Group. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • aged 18-65 years;
  • able to provide consent and complete all study materials;
  • consuming >5% of TEI from free sugars; and
  • residing in the South of England.

Exclusion criteria

  • individuals who are pregnant or breastfeeding;
  • underweight (BMI <18.5);
  • have pre-existing medical conditions affecting swallow ability, taste and smell perception;
  • currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
  • current smokers or have smoked within 3 months of the study start date;
  • have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions.

Treatment and study plan

Dietary recommendations

Behavioral

Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations

Primary outcomes

  1. Free Sugar Intakes

    Time frame: 12 weeks from baseline

    Percentage energy intake from free sugars, assessed using diet diaries

  2. Number of Participants Who Adhered to the Recommendations Provided

    Time frame: 12 weeks from baseline

    Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence

Secondary outcomes

  1. Dietary Intakes

    Time frame: 12 weeks from baseline

    Energy intake, assessed using diet diaries

  2. BMI

    Time frame: 12 weeks from baseline

    Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements

  3. Sweet Food Preferences

    Time frame: 12 weeks from baseline

    Preferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale, scored from 0-100mm. Higher scores signify stronger preferences

  4. Sweet Food Choices

    Time frame: 12 weeks from baseline

    Selection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured in terms of weight consumed

  5. Sweet Food Attitudes

    Time frame: 12 weeks from baseline

    Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using the SSS questionnaire (Tang et al., 2024, Appetite, 2024, 194, 107169. DOI: 10.1016/j.appet.2023.107169). Scales scored between 0 and 5. Higher scores denote stronger attitudes.

  6. Number of Participants Reporting Adverse Events

    Time frame: Baseline to 12 weeks

    Adverse events, assessed by self-report, measured in terms of number of participants rather than number of events

  7. Eating-based Attitudes

    Time frame: Baseline to 12 weeks

    Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)

  8. Eating-based Motivations

    Time frame: Baseline to 12 weeks

    Motivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84), with values raning from 1-5. Higher scores denote stronger motivations

  9. Quality of Life (Subjective Wellbeing)

    Time frame: Baseline to 12 weeks

    Quality of Life, measured using the Short Form - 36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, scored from 0-100, where a higher score demonstrates better quality of life

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Mar 25, 2021
Registry last updated
Jul 21, 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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