Effects of Pectin Supplementation on Frail Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.