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Completed

NCT Number: NCT06758570

Effect Dietary Fibre Supplementation on Gut Microbiota Composition

The study involves taking pectin fibre at increasing doses ranging from 5g, 10g and 15g for a total period of 6 weeks with the increase every 2 weeks. Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 4 occasions; at the start of the intervention and every 2 weeks, at the end of each dosing period. At each study visit (~3hrs), participants will be asked to provide a stool and blood sample and will have blood pressure measured. In the week before each study visit, participants will record their food intake.

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Key information

Conditions

Diet, Healthy Systemic Inflammatory Response

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

About this study

The study aims to assess the optimal dosage of pectin required to see beneficial effects on inflammation and gut microbiome composition. 15 healthy, non-obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and at the end of each dosing period (before each study visit), participants will be asked to complete a dietary record (4 days), to collect a stool sample on the day before the study visit and to fast from midnight the night before this visit.

At both study visits, participants will have weight, hip/waist circumference and blood pressure measured. They will be asked to complete some questionnaires. After completion of the first study day, participants will be provided with the required dosage of pectin for the 2-week dosing period. They will be given the required doses of pectin portioned in individual sachets, with instructions to add the contents of one sachet a day to juice, smoothies or water and to consume immediately. Study visits will be scheduled at the end of every 2-weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study
  • Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2

Exclusion criteria

  • Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
  • Are taking the following medications: immunosuppressants, anti-histamines, amiodarone and/or perhexiline
  • Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program/ taking prebiotic supplements
  • Pregnant or breast feeding
  • History or current psychiatric illness
  • History or current neurological condition (e.g. epilepsy)
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Treatment and study plan

Pectin dosages

Dietary Supplement

15 individuals were provided with increasing doses of pectin: 5g for 2 weeks 10g for 2 weeks 15 for 2 weeks

Primary outcomes

  1. Change in microbiome profile

    Time frame: 6 weeks

    Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks)

  2. Change in inflammatory profile

    Time frame: 6 weeks

    Change in circulating markers of inflammation measured by ELISAs in serum samples collected at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).

  3. Changes in short chain fatty acids (SCFAs)

    Time frame: 6 weeks

    Change in serum SCFAs measured by mass spectrometry at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).

Secondary outcomes

  1. Change in systolic blood pressure (lying to standing) pre intervention

    Time frame: 6 weeks

    Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit.

  2. Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score

    Time frame: 6 weeks

    Change in 'SF36' Questionnaire aggregated 'physical' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing; measured at the start and the end of each dosing period

  3. Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score

    Time frame: 6 weeks

    Change in 'SF36' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing; measured at the start and the end of each dosing period

  4. Dose response change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6 weeks

    Change in PSQI score (min score 0, max 21), measured at the start and the end of each dosing period, with higher score indicating poorer sleep quality

  5. Dose response change in Hospital Anxiety and Depression scores (HADS)

    Time frame: 6 weeks

    Change in anxiety score (min 0, max 3 which higher scores indicating higher anxiety like symptoms) and depression scores (min 3, max 0 which lower scores indicating higher depressive like symptoms), measured at the start and at the end of each dosing period

  6. Change in systolic blood pressure (lying to standing) post every dosing period

    Time frame: 6 weeks

    Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at the end of each dosing period (every 2 weeks)

  7. Change in diastolic blood pressure (lying to standing) post every dosing period

    Time frame: 6 weeks

    Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at the end of each dosing period (every 2 weeks)

  8. Change in diastolic blood pressure (lying to standing) at pre intervention study visit

    Time frame: 6 weeks

    Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), pre intervention

Sponsors and collaborators

Lead sponsor

Elizabeth Simpson

Other

Registry information

Official study title

The Modulatory Effects of Dietary Fibres on the Composition and Function of the Gut Microbiome- A Dose-response Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

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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