Effect Dietary Fibre Supplementation on Gut Microbiota Composition

NCT ID: NCT06758570

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diet, Healthy; Systemic Inflammatory Response

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dose response effect of Pectin

In order to investigate the dose-response effect of dietary pectin fibre, pectin was provided to healthy volunteers in increasing doses of 5g, 10g and 15g for a period of 2 weeks each with samples and data collected prior to each dosing period.

Group Type: EXPERIMENTAL

Pectin dosages

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Pectin dosages

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elizabeth Simpson

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Simpson

Senior Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ana Valdes, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

FMHS 302-0621(Dose response)

Identifier Type: -

Identifier Source: org_study_id