Effects of Pectin Supplementation on Frail Older Adults
The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
This study is testing if taking a daily pectin supplement can help frail older adults feel better and improve their health by looking at inflammation and gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Nottingham, Nottingham) |
| Trial ID | NCT06955975 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of daily intake of Low-methoxy (LM) pectin on systemic inflammation and gut microbiome composition in healthy elderly individuals showing early signs of frailty or pre-frailty. Participants will be randomly assigned to receive either pectin with whey protein and cocoa powder or a placebo for four weeks. They will attend two laboratory visits to provide stool and blood samples, and undergo assessments of physical functioning and quality of life. The study aims to explore the potential benefits of dietary fiber on health outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are healthy elderly individuals over 65 years old with a BMI between 18.5 and 39.9 who are classified as pre-frail or frail.
Not a fit: Patients with gastrointestinal conditions or those on specific medications that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this study could improve physical functioning and quality of life for frail older adults through dietary interventions.
How similar studies have performed: While dietary interventions for frailty are being explored, this specific approach using LM pectin is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nottingham, Nottingham
- University of Nottingham — Nottingham, Nottingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Professor Ana Valdes, PhD student candidate — University of Nottingham
- Study coordinator: Noor K Al-Tameemi, PhD student candidate
- Email: noorkifahabdulhussein.al-tameemi@nottingham.ac.uk
- Phone: 0044 01158231149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.