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

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).

Study Overview

• Status: Recruiting
• Conditions: Frailty; Diet; Systemic Inflammatory Response; Dietary Fiber; Frailty at Older Adults; Pre-Frailty
• Intervention / Treatment: Dietary supplement: Pectin; Other: Whey protein

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noor K Al-Tameemi, PhD student candidate; Phone Number: 0044 01158231149; Email: noorkifahabdulhussein.al-tameemi@nottingham.ac.uk
• Study Contact Backup: Name: Professor Ana Valdes; Phone Number: 0044 0115 969 1169; Email: Ana.Valdes@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Recruiting
    • University of Nottingham
    • Contact: Noor K Al-Tameemi, PhD Student Candidate; Phone Number: 004401158231149; Email: noorkifahabdulhussein.al-tameemi@nottingham.ac.uk
    • Contact: Professor Ana Valdes; Phone Number: 00440115 969 1169; Email: Ana.Valdes@nottingham.ac.uk
    • Principal Investigator: Professor Ana Valdes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• 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 Frailty Questionnaire).

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 the study.
• History of gastrointestinal resection surgery, including bariatric surgery.
• Used of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.
• 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.
• 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 invasive procedures or an inconvenience allowance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pectin; 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour will be provided to participants for 4 weeks.	Dietary supplement: Pectin; 10g 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.
Placebo Comparator: Whey protein; 10g of whey protein with 10g of cocoa powder added as flavour will be provided to participants for 4 weeks.	Other: Whey protein; 10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure (lying to standing) post intervention	Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit	4 minutes
Change in Hospital Anxiety and Depression Score (HADS)	Change in anxiety score (min score 0, max 3 with higher score indicating higher anxiety like symptoms), and depression score (min 3, max 0 with lower the scores indicating higher depression like symptoms) measured pre and post the 4-week intervention.	4 weeks
Change in systolic blood pressure (lying to standing) pre intervention	Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit.	4 minutes
Change in diastolic blood pressure (lying to standing) pre intervention	Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit.	4 minutes
Change in diastolic blood pressure (lying to standing) post intervention	Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit.	4 minutes
Change in body mass index (BMI)	Change in BMI pre and post the 4-week intervention period.	4 weeks
Change in waist-to-hip ratio (WHR)	Change in WHR pre and post the 4-week intervention period.	4 weeks
Change in time up and go test (TUG)	Change in TUG pre and post the 4-week intervention period.	4 weeks
Change in 30-second sit to stand test	Change in 30-second sit to stand test pre and post the 4-week intervention period.	4 weeks
Change in 36-Item Short Form Survey (SF-36) Questionnaire	Change in SF-36 scores pre and post intervention.	4 weeks

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Professor Ana Valdes, PhD student candidate, University of Nottingham; Study Director: Noor K Al-Tameemi, PhD student candidate, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Systemic inflammation; Frailty; Gut microbiome; Dietary intervention; Pectin; Pre-Frailty; LM Pectin
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: FMHS 280-0924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The research team will try their best to share statistical plan with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No