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

Last updated: June 17, 2025
Sponsor: University of Nottingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diet And Nutrition

Treatment

Whey protein

Pectin

Clinical Study ID

NCT06955975
FMHS 280-0924
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in thestudy.

  • Participant eligibility includes those aged >65 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2.

  • Participants who are considered as pre-frail or frail based on FRAIL (Simple FrailtyQuestionnaire).

Exclusion

Exclusion Criteria:

  • Have gastrointestinal conditions e.g. malabsorptive conditions such as IBS/IBD,coeliac or functional conditions such as gastroparesis or food intolerances etc.

  • History of major surgery which potentially limit participation or completion of thestudy.

  • History of gastrointestinal resection surgery, including bariatric surgery.

  • Used of antibiotics, antifungal medications, probiotics or prebiotics 90 days beforethe start of the study.

  • Are taking the following medications: immunosuppressants, amiodarone and/orperhexiline.

  • Are currently following or anticipated to commence a specialised commerciallyavailable weight loss diet and/or program.

  • History of side effects towards probiotics or prebiotics.

  • 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 invasiveprocedures or an inconvenience allowance.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Whey protein
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • University of Nottingham

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

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