disease related malnutrition / malnutrition
Conditions
Interventions
 
Subjects that are eligible for study participation will be randomly allocated 
to receive either the Test Product or the Control Product for a period of 4 
weeks. 
Sponsors
Danone Global research & Innovation center
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
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. Willing to maintain dietary habits for the duration of the study. 5. Written informed consent from subject. 6. Have access to a freezer and willing to store the stool samples in it.
Exclusion criteria
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 (V1) and / or will not refrain from using these kinds of products during the study period. 3.Admitted to hospital. 4.Excessive alcohol consumption (use of > 10 units per week or > 2 units per day on average during the past 6 months). 5.Change in smoking habits (start or stop during the study).. 6.Known allergy to cow’s milk protein. 7.Known allergy to soy protein 8.Known galactosaemia. 9.Known hepatic encephalopathy. 10.Any antecedents of digestive surgery performed less than 5 years before the screening visit (except for appendectomy and cholecystectomy performed more than 2 years before the screening visit), or plan for such surgery during the study. 11.Known Irritable Bowel Syndrome. 12.Known lactose intolerance without using lactase. 13.Known history of intestinal polyp removal within 3 months prior to the study. 14.Known history of Immunotherapy within 5 years before the screening visit. 15.Known history of GI cancer within 5 years before the screening visit. 16.Active cancer treatment or within 12 months prior the study 17.Diagnose of Celiac Disease. 18.Received antibiotics (systemic) within 4 weeks prior to study. 19.Patients following a vegan or vegetarian diet. 20.Active flare of inflammatory bowel disease as defined by HBI >6 (Crohn’s disease) or SCCAI >5 (ulcerative colitis). 21.Stricturing Crohn’s disease. 22.Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis. 23.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. 24.Planned hospital admission during the study. 25.Planned dental surgery during the study. 26.Participation in any other studies involving investigational or marketed products concomitantly or within 6 weeks prior to baseline. 27.Severe disease with life expectancy less than a year. 28.If the subject is unable to sign the Informed Consent themselves.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is the change in gut microbiota bifidobacteria levels (?V3-V1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters in this study are: - Changes in gut microbiota composition (?V3-V1 analysed between and within groups). - Fecal pH and Total short-chain fatty acids (SCFA) (?V3-V1 analysed between and within groups). - Stool frequency and consistency assessed by the Bristol Stool Form Scale (BSFS) (?V3-V1 analysed between and within groups) | — |
Countries
Belgium, Netherlands, Poland
Contacts
Public ContactR.A. Pian
Danone Global research & Innovation center
Outcome results
None listed