Ziekte gerelateerde ondervoeding 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 8
weeks.
Sponsors
Danone Global R&I Center
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2.Identified as at medium or high risk of malnutrition based on: a) MUST score >= 1 and / or b)Being prescribed with ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study 3. In need of 2 servings of ONS/day (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional. 4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator. 5. Willing to maintain dietary habits for the duration of the study. 6. Willing to consume plant based as well as dairy based ONS.
Exclusion criteria
Exclusion criteria: 1. Known allergy to soy, cow*s milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (PIB) and the appendix of this protocol). 2. Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). Subjects with lactose intolerance who use lactase may still be enrolled in the study. 3. Known galactosaemia 4. Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis. 5. Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) >6 (Crohn*s disease) or Simple Clinical Colitis Activity Index (SCCAI) >5 (ulcerative colitis). 6. Recent history of gastrointestinal surgery (except appendectomy) that interferes with the GI function, e.g. ileostomy, colostomy, (partial) gastrectomy or any other procedure for stomach volume reduction including gastric banding, within four weeks prior to the screening visit. 7. Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome of the study: To investigate the effect of PB HEHP ONS compared to DB HEHP ONS on nutritional intake (energy & protein) in subjects with or at risk of Disease Related Malnutrition (DRM) and/or prescribed with ONS.* | — |
Secondary
| Measure | Time frame |
|---|---|
| other outcomes of the study: To investigate the effect of PB HEHP ONS compared to DB HEHP ONS in subjects with or at risk of DRM and/or prescribed with ONS prior to the study on:* - Safety and gastrointestinal (GI) tolerance* - Compliance** - Product experience & liking* - Changes in anthropometry (BW, BMI)* - Changes in blood nutrient status (Vitamin D (25(OH)D), ferritin, zinc, calcium, parathyroid hormone (PTH)* - Changes in percentage of subjects with or at risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST).* - Changes in health-related quality of life (QoL) (EQ-5D-5L)* - Changes in muscle strength & function (Hand Grip Strength & x 5 sit to stand test).** | — |
Countries
Netherlands
Outcome results
None listed