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RecruitingNCT06955975

The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
University of Nottingham · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

Summary

The study involves the intake of Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), to test their effects on systematic inflammation in the body and gut microbiome composition. Study subjects will be healthy elderly with early signs of frailty or pre-frailty from the local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour (active arm) or 10g of whey protein with 10g of cocoa powder added as flavour (placebo). Participants will be given the blinded products portioned in individual sachets, with instructions to add the contents of one sachet a day to 150ml of milk and to consume immediately. At each study visit (\~90 minutes), participants will be asked to provide a stool and blood sample, will have blood pressure, heart rate, weight, height, and waist/hip ratio measured, research team will perform physical functioning test (Time up and go test, 30-second sit to stand test) as well as participants will complete the quality-of-life questionnaire (SF-36), the Depression and Anxiety (HADS) and the Gastrointestinal Symptom Rating Scale (GSRS).

Detailed description

The overall aim of the proposed project is to study the effect of daily ingestion of a dietary fibre (LM pectin) among frail population on anti-inflammatory and cardioprotective metabolic measures and to determine whether effects are mediated via the modulation of the gut microbiome and SCFAs production. Specific Aim 1: To determine the effects of 4-weeks' pectin dietary supplementation on gut microbiome composition and diversity and the concentration of markers of intestinal permeability in the blood. Specific Aim 2: To investigate the impact of daily pectin intake on physical functioning and subjective quality of life. Specific Aim 3: To investigate the consequences of 4-weeks' daily ingestion of pectin on subjective measures of depression and anxiety among frail participants. 30 healthy elderly with early signs of frailty or pre-frailty will be recruited following a successful medical screening.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPectin10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour were randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.
OTHERWhey protein10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin.

Timeline

Start date
2025-02-10
Primary completion
2026-03-31
Completion
2026-03-31
First posted
2025-05-02
Last updated
2025-06-22

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT06955975. Inclusion in this directory is not an endorsement.