Study to Evaluate Bioactive Peptides' Effect on Digestive Discomfort Symptoms of the Elderly (NCT04450979) | Clinical Trial Compass
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 range65 Years – 75 Years
SexALL
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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…
What they're measuring
1
Digestive symptom frequency questionnaire
Timeframe: Baseline (week 0) and end of treatment (week 12)