NCT06955975 The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
| NCT ID | NCT06955975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Frailty at Older Adults |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-02-10 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Noor K Al-Tameemi, PhD student candidate
✉ noorkifahabdulhussein.al-tameemi@nottingham.ac.uk📞 0044 01158231149
Professor Ana Valdes, PhD student candidate
PRINCIPAL INVESTIGATOR
University of Nottingham
Frequently Asked Questions
Who can join the NCT06955975 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Frailty at Older Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06955975 currently recruiting?
Yes, NCT06955975 is actively recruiting participants. Contact the research team at noorkifahabdulhussein.al-tameemi@nottingham.ac.uk for enrollment information.
Where is the NCT06955975 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT06955975 clinical trial?
NCT06955975 is sponsored by University of Nottingham. The principal investigator is Professor Ana Valdes, PhD student candidate at University of Nottingham. The trial plans to enroll 30 participants.