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

NCT ID: NCT06480799

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diet, Healthy; Systemic Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Fibre arm

15g of pectin and 5g Inulin provided to healthy participants for 4 weeks.

Group Type: ACTIVE_COMPARATOR

Fibre intervention

Intervention Type: 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.

Maltodextrin

10g of maltodextrin provided as the control to participants for 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo intervention

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Fibre intervention

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo intervention

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

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, 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)

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

Sponsors

Elizabeth Simpson

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Simpson

Principal Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ana Valdes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

FMHS 287-0523

Identifier Type: -

Identifier Source: org_study_id