No registrations found.
ID
Source
Brief title
Health condition
NA
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter in this study is the composite satiety score (CSS), measured from baseline until 120 minutes after starting the consumption of the study product:
- Area under the curve (AUC; score x minutes)
- Incremental area under the curve (iAUC; score x minutes)
- Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product
- Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product
The CSS will be calculated through the equation (satiety + fullness + (100 – hunger) + (100 – prospective food consumption))/ 4. Satiety, fullness, hunger and prospective food consumption will be assessed on a VAS, with scores ranging from 0 to 100. The CSS also ranges from 0 to 100.
Secondary outcome
Other outcome parameters in this study are:
-Satiety, fullness, hunger, prospective food consumption measured from baseline until 120 minutes after starting the consumption of the study product
- AUC (score x minutes)
- iAUC (score x minutes)
- Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product
- Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after starting the consumption of the study product
-Adherence to use of the study product, defined as volume consumed within 15 minutes relative to 1 serving (%)
-Overall liking of the study product (score), assessed 15 minutes after starting the consumption of the study product on a liking scale ranging from 1 to 10.
Background summary
This is a randomised, controlled, single-blind, multi-centre, cross-over study to explore the effects of adding an appetite stimulant to an ONS compared with an ONS without this appetite stimulant in nursing home residents on appetite-related outcomes.
Study objective
H0: The effect of using the test product is equal to the effect of using control product with respect to the CSS (Composite Satiety Score) in nursing home residents
H1: The effect of using the test product is unequal to the effect of using control product with respect to the CSS in nursing home residents
Study design
V0 (screening); V1 (first test day within 10 days after visit 0); V2 (22-48 hours after V1) V3 (second test day 2-14 days after first test day), V4 (22-48 hours after V3)
Intervention
Duration of intervention: 2 weeks
Intervention group: One bottle of ONS (125 mL), mixed with an appetite stimulant dissolved in 5 mL of water
Control group: One bottle of ONS (125 mL) mixed with 5 mL of water
Danone Nutricia Research
+31 30 2095 000
register.clinicalresearchnutricia@danone.com
Danone Nutricia Research
+31 30 2095 000
register.clinicalresearchnutricia@danone.com
Inclusion criteria
1. 65 years of age or older
2. Residing in a nursing home
3. Able to consume high energy and/or high protein ONS at discretion of the Investigator
4. Written informed consent
Exclusion criteria
1. Any known gastrointestinal (GI) disease that interferes with the gastrointestinal motility and nutritional intake, e.g. constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis
2. Any known metabolic condition that interferes with the breakdown of amino acids
3. History of GI 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
4. 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
5. Known allergy to cow’s milk protein
6. Known galactosaemia
7. Known severe lactose intolerance without using lactase
8. Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9612 |
| CCMO | NL77775.100.21 |
| OMON | NL-OMON52167 |