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

NCT06480799 | Completed

• 1 other identifier: FMHS 287-0523
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy; Systemic Inflammatory Response

Keywords

Dietary intervention; Gut microbiome; Systemic inflammation

Outcome Measures

Primary Outcomes (3)

• Change in microbiome profile

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

  4 weeks

• Change in inflammatory profile

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

  4 weeks

• Changes in short chain fatty acids (SCFAs)

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

  4 weeks

Secondary Outcomes (12)

• Change in heart rate variability

  4-weeks

• Change in physical activity level (PAL)

  4-weeks

• Change in step count

  4-weeks

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

  4 minutes

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

  4 minutes

Study Arms (2)

Fibre arm

ACTIVE COMPARATOR

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

Dietary Supplement: Fibre intervention

Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo intervention

Interventions

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.

Fibre arm

Placebo intervention DIETARY_SUPPLEMENT

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

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elizabeth Simpson: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Study Officials

• Ana Valdes, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded study
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Research Fellow

Model Details: Controlled intervention

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: September 22, 2021
• Primary Completion: August 28, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)