Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota in Older Adults with or At Risk of Disease Related Malnutrition (BISON)
Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota Bifidobacteria in Older Adults with or At Risk of Disease Related Malnutrition
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Danone Global Research & Innovation Center
- Phone Number: +31 30 2095 000
- Email: register.clinicalresearchnutricia@danone.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. 65 years of age or older 2. Identified as at medium or high risk of malnutrition based on:
a) MNA-SF score between 0 - 11 and / or b) are prescribed with ONS 3. In need of 2 servings of oral nutritional support/day (300 kcal; 12 gr protein per serving).
4. a) Not being prescribed with ONS or b) being prescribed with non-fibre containing ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study.
5. Willing to maintain dietary habits for the duration of the study. Written informed consent from subject (or impartial witness after verbal consent of subject when subject is physically unable to sign and where allowed by local regulations).
Exclusion Criteria:
1. Requirement for a fibre-free diet. 2. Have used nutritional supplements with fibre/prebiotics and/or probiotics content at any point during 3 weeks prior to start study (Visit 1) and / or will not refrain from using these kinds of products during the study period.
3. Admitted to an intensive care unit. 4. Hemodynamically unstable. 5. Known allergy to cow's milk protein. 6. Known galactosaemia. 7. Known hepatic encephalopathy. 8. Known Irritable Bowel Syndrome. 9. Known severe lactose intolerance without using lactase. 10. Known history of GI surgery. 11. Known history of intestinal polyp removal within 3 months prior to the study.
12. Known history of Immunotherapy. 13. Known history of GI cancer. 14. Active cancer treatment or within 12 months prior the study 15. Diagnose of Celiac Disease. 16. Received antibiotics within 4 weeks prior to study. 17. Patients following a vegan or vegetarian diet. 18. Active flare of inflammatory bowel disease as defined by HBI >6 (Crohn's disease) or SCCAI >5 (ulcerative colitis).
19. Stricturing Crohn's disease. 20. Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
21. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease.
22. Planned hospital admission during the study period in case not hospitalised at screening 23. Participation in any other studies involving investigational or marketed products concomitantly or within 6 weeks prior to baseline.
24. Severe disease with life expectancy less than a year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
ONS including fibre (300 kcal, 12gr protein, 125 mL, 4.5 g fibre), The subjects will use study products twice daily for 4 weeks starting at V1.
|
One drink will be tested
|
|
Experimental: Arm 2
ONS without fibre (300 kcal, 12gr protein, 125 mL, 0 g fibre), The subjects will use control products twice daily for 4 weeks starting at V1.
|
One drink will be tested
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in gut microbiota bifidobacterial levels
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in gut microbiota composition
Time Frame: 4 weeks
|
4 weeks
|
|
Fecal pH
Time Frame: 4 weeks
|
4 weeks
|
|
Stool frequency and consistency assessed by the Bristol Stool Form Scale (BSFS)
Time Frame: 4 weeks
|
4 weeks
|
|
Total short-chain fatty acids (SCFA)
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23REX0060367
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.