Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
NCT06955975

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

Led by University of Nottingham · Updated on 2025-06-22

30

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give informed consent for participation in the study
  • Aged over 65 years
  • Body mass index (BMI) between 18.5 and 39.9 kg/m2
  • Considered pre-frail or frail based on the Simple Frailty Questionnaire (FRAIL)
Not Eligible

You will not qualify if you...

  • Gastrointestinal conditions such as IBS, IBD, coeliac disease, gastroparesis, or food intolerances
  • History of major surgery limiting study participation or completion
  • History of gastrointestinal resection surgery, including bariatric surgery
  • Use of antibiotics, antifungal medications, probiotics, or prebiotics within 90 days before the study
  • Taking immunosuppressants, amiodarone, or perhexiline
  • Currently following or planning to start a specialized commercial weight loss diet or program
  • History of side effects to probiotics or prebiotics
  • History or current psychiatric illness
  • History or current neurological condition, such as epilepsy
  • Participation in another research study involving invasive procedures or inconvenience allowance in the last 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Nottingham

Nottingham, Nottingham, United Kingdom, NG7 2UH

Actively Recruiting

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Research Team

N

Noor K Al-Tameemi, PhD student candidate

CONTACT

P

Professor Ana Valdes

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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