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Completed

NCT Number: NCT06480799

Effect of Pectin and Inulin Fibre Supplementation on Glucose and ANS Modulation

The study involves intake of dietary supplements, which are commonly found in the UK diet (not pharmacological agents) to test their effects on inflammation in the body and gut microbiome composition. Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either the dietary fibres (Pectin and Inulin) or placebo (maltodextrin). At each study visit (~3hrs), participants will be asked to provide a stool and blood sample and will have blood pressure measured. They will also consume a glucose drink to assess how effectively the body regulates its blood glucose concentration. In the week before each study visit, participants will wear an activity and glucose monitor and record their food intake.

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Key information

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 overall aim of the proposed project is to unlock the effect of two structurally different dietary fibres on anti-inflammatory and cardioprotective metabolic responses via the modulation of the gut microbiome and SCFAs production.

Specific Aim 1: To deliver a wealth of molecular data, including effect sizes, on the physiological effects of two distinct fibres on the changes in the composition and function of the gut microbiome and changes in the metabolomic and physiological profile of an individual.

Specific Aim 2: To investigate the mechanisms whereby the gut microbiome modulates crucial physiological parameters such, blood glucose regulation, hunger and appetite, immune function markers in response to the anti-inflammatory effects of the gut microbiome.

30 healthy, non obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and in the final week of the 4-week intervention (before the second study visit), participants will be asked to wear a wrist-worn activity monitor and a subcutaneous glucose monitor (Freestyle Libre 2; 7 days), 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 consume 75g of glucose in 300ml of water (as an oral glucose challenge) and glucose concentration will be monitored over 2 hours via the subcutaneous monitor. They will also be asked to complete some questionnaires. After completion of the first study day, participants will be randomised to receive either the dietary fibres or placebo powder. They will be given the blinded products 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 visit 2 will be scheduled at the end of the 4 week 'dosing' period.

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, amiodarone and/or perhexiline
  • Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
  • 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 (this must remain for ALL UoN FMHS UREC approved studies)

Treatment and study plan

Fibre intervention

Dietary Supplement

Inulin fibre (5g) and Pectin fibre (15g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.

Placebo intervention

Dietary Supplement

Maltodextrin (10g) served as a control/ placebo to compare the effects observed with inulin and pectin.

Primary outcomes

  1. Change in microbiome profile

    Time frame: 4 weeks

    Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period

  2. Change in inflammatory profile

    Time frame: 4 weeks

    Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period.

  3. Changes in short chain fatty acids (SCFAs)

    Time frame: 4 weeks

    Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period

Secondary outcomes

  1. Change in heart rate variability

    Time frame: 4-weeks

    change in mean heart rate variability, measured across 7 days using a wrist worn activity monitor, before and in the final week of the 4-week intervention

  2. Change in physical activity level (PAL)

    Time frame: 4-weeks

    change in mean PAL, measured across 7 days using a wrist worn activity monitor, before and in the final week of the 4-week intervention

  3. Change in step count

    Time frame: 4-weeks

    change in mean step count, measured across 7 days using a wrist worn activity monitor, before and in the final week of the 4-week intervention

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

    Time frame: 4 minutes

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

  5. Change in systolic blood pressure (lying to standing) post intervention

    Time frame: 4 minutes

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

  6. Change in diastolic blood pressure (lying to standing) pre-intervention

    Time frame: 4 minutes

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

  7. Change in diastolic blood pressure (lying to standing) post-intervention

    Time frame: 4 minutes

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

  8. Change in heart rate (lying to standing) pre-intervention

    Time frame: 4 minutes

    Change in heart rate (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit

  9. Change in heart rate (lying to standing) post-intervention

    Time frame: 4 minutes

    Change in heart rate (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit

  10. Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score

    Time frame: 4 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 pre and post intervention

  11. Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score

    Time frame: 4 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 mental wellbeing; measured pre and post intervention

  12. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 weeks

    Change in PSQI score (min score 0, max 21), measured pre and post the 4-week intervention, with higher score indicating poorer sleep quality

Sponsors and collaborators

Lead sponsor

Elizabeth Simpson

Other

Registry information

Official study title

The Role of Dietary Fibres in Modulating Blood Glucose and the Autonomic Nervous System - A Pilot Randomised Placebo-controlled Dietary Intervention Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2024
Registry last updated
Mar 28, 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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