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The Effects of Dietary Fibres on Metabolic Health and the Gut Microbiome

NCT ID: NCT06580132

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-09

Study Completion Date

2022-09-09

Brief Summary

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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 (the current trial focussed on pectin) 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. In the week before each study visit, participants will record their food intake.

Detailed Description

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The overall aim of the proposed project is to unlock the effect of dietary fibres (i.e. LM Pectin) 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 dietary 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 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 randomised to receive either the dietary fibre 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.

Conditions

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Diet Healthy Systemic Inflammatory Response

Keywords

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Dietary intervention Gut microbiome Systemic inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Controlled intervention
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Single blinded study

Study Groups

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Fibre arm (Pectin)

20g of pectin was provided to healthy volunteers for 4 weeks.

Group Type ACTIVE_COMPARATOR

Pectin

Intervention Type DIETARY_SUPPLEMENT

Pectin fibre (20g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.

Maltodextrin

10g of maltodextrin was provided to healthy volunteers for 4 weeks

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Pectin

Pectin fibre (20g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

The participant may not enter the study if ANY of the following apply:

* 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/ taking prebiotic supplements
* Pregnant or breastfeeding
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elizabeth Simpson

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Simpson

Senior Research Fellow

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ana Valdes, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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University of Nottingham

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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FMHS 302-0621

Identifier Type: -

Identifier Source: org_study_id