NCT04450979

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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2017

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

June 25, 2020

Last Update Submit

April 6, 2022

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • Digestive symptom frequency questionnaire

    The primary endpoint is the difference between the change experienced over 12 weeks in the active group versus the change in the placebo group using the digestive symptom frequency questionnaire (DSFQ) at baseline and end of treatment

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

Secondary Outcomes (7)

  • To determine the effect of supplementation of a Bioactive Peptide on muscle mass

    Baseline (week 0) and week 12

  • To determine the effect of supplementation of a Bioactive Peptide on upper body muscle strength

    Baseline (weeks 0) and week 4, week 8 and week 12

  • To determine the effect of supplementation of a Bioactive Peptide on lower body muscle strength

    Baseline (weeks 0) and week 4, week 8 and week 12

  • To determine the effect of supplementation of a Bioactive Peptide on physical performance

    Baseline (weeks 0) and week 12

  • To determine the effect of supplementation of a Bioactive Peptide on blood glucose

    Baseline (weeks 0) and week 12

  • +2 more secondary outcomes

Study Arms (2)

Bioactive hydrolysate

ACTIVE COMPARATOR

20 g of hydrolysed rice protein

Dietary Supplement: Bioactive hydrolysate

Placebo

PLACEBO COMPARATOR

20 g micro crystalline cellulose

Dietary Supplement: Bioactive hydrolysate

Interventions

Bioactive hydrolysateDIETARY_SUPPLEMENT

Participants given a bioactive vegetable hydrolysate to take one dose each morning and one dose each evening for the duration of the study.

Bioactive hydrolysatePlacebo

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

June 14, 2016

Primary Completion

October 28, 2016

Study Completion

January 20, 2017

Last Updated

April 14, 2022

Record last verified: 2022-04