An exploratory study investigating the effect of adding an appetite stimulant to an ONS on appetite-related outcomes in nursing home residents and in older adults in need of additional nutritional support
- Conditions
- geen aandoening, doelgroep is kwetsbare ouderenfullnesssatiety
- Registration Number
- NL-OMON52167
- Lead Sponsor
- utricia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
1. 65 years of age or older
2. Residing in a nursing home
OR
If not residing in a nursing home, in need of additional nutritional support:
defined as currently prescribed with oral nutritional supplements (ONS) or
being identified as malnourished/at risk of malnutrition based on the MNA-SF.
3. Able to consume high energy and/or high protein ONS at discretion of the
Investigator
4. Written informed consent
1. Any known gastrointestinal (GI) disease that interferes with the GI 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 (e.g. arginase deficiency, urea cycle disorder)
3. Known 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, e.g. due to the presence of a
psychiatric disorder (e.g. major depression, psychoses), dementia or
Alzheimer*s disease
5. Known renal dysfunction (e.g. estimated Glomerular Filtration Rate <30
mL/min/1.73 m2)
6. Known allergy to cow*s milk protein
7. Known galactosaemia
8. Known severe lactose intolerance without using lactase
9. Enrolment in any other studies involving investigational or marketed
products concomitantly within two weeks prior to baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcome parameter in this study is the composite satiety score (CSS),<br /><br>measured from baseline until 120 minutes after starting the consumption of the<br /><br>study product:<br /><br>- Area under the curve (AUC; score x minutes)<br /><br>- Incremental area under the curve (iAUC; score x minutes)<br /><br>- Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and<br /><br>120 minutes after starting the consumption of the study product<br /><br>- Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after<br /><br>starting the consumption of the study product<br /><br><br /><br>The CSS will be calculated through the equation (satiety + fullness + (100 -<br /><br>hunger) + (100 - prospective food consumption))/ 4. Satiety, fullness, hunger<br /><br>and prospective food consumption will be assessed on a VAS, with scores ranging<br /><br>from 0 to 100. The CSS also ranges from 0 to 100. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Other outcome parameters in this study are:<br /><br><br /><br>Satiety, fullness, hunger, prospective food consumption measured from baseline<br /><br>until 120 minutes after starting the consumption of the study product<br /><br>- AUC (score x minutes)<br /><br>- iAUC (score x minutes)<br /><br>- Absolute values (score) at baseline (-5 minutes) and 15, 30, 45, 60, 90 and<br /><br>120 minutes after starting the consumption of the study product<br /><br>- Change from baseline (score) at 15, 30, 45, 60, 90 and 120 minutes after<br /><br>starting the consumption of the study product<br /><br><br /><br>Adherence to use of the study product, defined as volume consumed within 15<br /><br>minutes relative to 1 serving (%)<br /><br>Overall liking of the study product (score), assessed 15 minutes after starting<br /><br>the consumption of the study product on a liking scale ranging from 1 to 10.</p><br>