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

NCT06955975 | Recruiting

• 1 other identifier: FMHS 280-0924
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Frailty at Older Adults; Pre-Frailty; Frailty; Diet; Dietary Fiber; Systemic Inflammatory Response

Keywords

Pectin; LM Pectin; Frailty; Pre-Frailty; Systemic inflammation; Dietary intervention; Gut microbiome

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 (10)

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

  4 minutes

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

  4 minutes

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

  4 minutes

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

  4 minutes

• Change in body mass index (BMI)

  4 weeks

Study Arms (2)

Pectin

ACTIVE COMPARATOR

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

Whey protein

PLACEBO COMPARATOR

10g of whey protein with 10g of cocoa powder added as flavour will be provided to participants for 4 weeks.

Other: Whey protein

Interventions

Pectin DIETARY_SUPPLEMENT

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.

Pectin

Whey protein OTHER

10g of whey protein with 10g of cocoa powder added as flavour served as the control/ placebo to compare the effects observed with pectin.

Whey protein

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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 \>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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Pectins; Whey Proteins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Professor Ana Valdes, PhD student candidate

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Noor K Al-Tameemi, PhD student candidate

  University of Nottingham

  STUDY DIRECTOR

Central Study Contacts

Noor K Al-Tameemi, PhD student candidate

CONTACT

0044 01158231149; noorkifahabdulhussein.al-tameemi@nottingham.ac.uk

Professor Ana Valdes

CONTACT

0044 0115 969 1169; Ana.Valdes@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Genetic and Molecular Epidemiology

Model Details: Controlled intervention

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: February 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

GB (1)