Status:
COMPLETED
Study to Evaluate Bioactive Peptides' Effect on Digestive Discomfort Symptoms of the Elderly
Lead Sponsor:
Nuritas Ltd
Collaborating Sponsors:
Atlantia Food Clinical Trials
Conditions:
Abdominal Pain
Eligibility:
All Genders
65-75 years
Phase:
NA
Brief 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 f...
Detailed Description
Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort will be randomised. Subjects will be randomised to receive either the Bioactive peptide or placebo for a total...
Eligibility Criteria
Inclusion
- 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
- 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 replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid
- Has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
Key Trial Info
Start Date :
June 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04450979
Start Date
June 14 2016
End Date
January 20 2017
Last Update
April 14 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.