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New treatment option for Frailty at Older Adults
Official title The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
ClinicalTrials.gov ID: NCT06955975
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join if
- Have gastrointestinal conditions e.g. malabsorptive conditions such as IBS/IBD, coeliac or functional conditions such as gastroparesis or food...
- 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, Nottingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.