The main objective of this study is to explore the acute effects of adding an appetite stimulant to an ONS on the composite satiety score (CSS, a combined score of satiety, fullness, hunger and prospective food consumption) compared with an ONS…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening, doelgroep is kwetsbare ouderen
Research involving
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
Malnutrition is a widespread problem affecting the lives of millions of people
each year. Oral nutritional supplements (ONS) have proven clinical benefits for
malnourished patients: ONS use is linked to lower mortality and lower
complication rates when compared to standard care.
Good adherence to ONS prescription is crucial to achieve the goals that are
aimed for. A lack of appetite and increased feeling of fullness in older adults
are being recognized as important barriers to consuming a bottle of ONS and
thereby adherence.
Anorexia of ageing is a reduced appetite and/or food intake in old age. One of
the underlying mechanisms for this relates to gastrointestinal motility
changes, resulting in early/postprandial satiety. Product AS-2, an appetite
stimulant, promotes gastric emptying and relaxation of the stomach and thereby
reduces the increased feeling of fullness.
This study is an exploratory study investigating the effect of a new product
concept, an ONS with the addition of an appetite stimulant (AS-2), on
appetite-related outcomes in nursing home residents and in older adults in need
of additional nutritional support.
The hypothesis formulation for the primary outcome parameter is:
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 and in older adults in need of additional nutritional support.
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 and in older
adults in need of additional nutritional support
Study objective
The main objective of this study is to explore the acute effects of adding an
appetite stimulant to an ONS on the composite satiety score (CSS, a combined
score of satiety, fullness, hunger and prospective food consumption) compared
with an ONS without this appetite stimulant in nursing home residents and in
older adults in need of additional nutritional support. The CSS will be
assessed from baseline until 120 minutes after starting the consumption of the
study product.
The other objectives of this study are to explore the effects of adding an
appetite stimulant to an ONS compared with an ONS without this appetite
stimulant in nursing home residents and in older adults in need of additional
nutritional support, on the following outcome parameters:
- Satiety
- Fullness
- Hunger
- Prospective food consumption
- Adherence (defined as volume consumed within 15 minutes relative to 1 serving)
- Overall liking
Study design
A randomised, controlled, single-blind, multi-centre cross-over study
Intervention
All subjects will consume both study products (the test product and control
product) on two separate test days (Visit 1 and Visit 3). Subjects will be
randomly allocated to receive either the test product or the control product at
the first test day. Subjects will receive the other product at the second
testday.
Study burden and risks
There are no Adverse Events expected associated with participation
Subjects are not expected to benefit from participation
Participation in the study means an investment of time by the subject for a
screening visit, 2 test days and 2 follow-up appointments.
The subjects regularly complete questionnaires during participation.
The subjects are asked to follow some instructions regarding food, drink and
activity level on test days.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Netherlands Trial Register: Trial NL9612 |
| CCMO | NL77775.100.21 |
| OMON | NL-OMON22468 |