CompletedNot Applicable

Study to Evaluate Bioactive Peptides' Effect on Digestive Discomfort Symptoms of the Elderly

40 participantsStarted 2016-06-14

Plain-language summary

This trial will investigate the potential of a bioactive peptide to reduce symptoms of digestive discomfort in a generally healthy elderly population. Participants will consume the bioactive peptide for 12 weeks and various measures indicating an improvement in health and well being will be taken throughout the trial. It is believed that consumption of the study product will reduce the severity of digestive discomfort, reduce chronic inflammation, improve blood glucose metabolism and improve physical performance.

Who can participate

Age range

65 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be able to give written informed consent * Be between 65 and 75 years of age (inclusive) * Have symptoms of digestive pain \& discomfort * Have a Fried Frailty score of \<2 * Have a Short physical performance battery (SPPB) score of \>5 and \<10 * Have a Mini Mental State Exam (MMSE) score \>24 * Have low or moderate activity according to the IPAQ short form * Have a BMI \<30 kg/m2 * Be in good general health. Exclusion Criteria: * Are less than 65 and greater than 75 years of age * Are severely immunocompromised (HIV positive, transplant Subject, on antirejection medications, on a steroid for \>30 days. * Have a diagnosis of Irritable Bowel Syndrome * Is taking a high dose of statins and/or has changed had their dose modified in the previous 6 months * Is experiencing muscle pain, soreness or muscle loss in the previous 6 months * Has a history of drug and / or alcohol abuse at the time of enrolment * Has changed their dietary habit within the preceding month * Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease * Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days * Has known allergy to components of the test product * Use of anti-inflammatory steroid medications, anticoagulants, current/recent (3 months) history of anabolic steroid, corticosteroid or estrogen use, testosterone replaceme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Digestive symptom frequency questionnaire

Timeframe: Baseline (week 0) and end of treatment (week 12)

Trial details

NCT IDNCT04450979

SponsorNuritas Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10-28

View on ClinicalTrials.gov More Abdominal Pain trials