During the study, the effects of the test product in ONS are examined:* Test product l-Arginine and l-Glutamate as separate amino acids that are combined This study examines the effects of adding the test product in ONS when compared to the ONS…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Geen, het betreft oudere volwassen zonder specifieke aandoening
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.
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. The CSS ranges from
0 to 100.
Secondary outcome
Other outcome parameters in this study are:
Composite satiety score (CSS) from baseline until 120 minutes after starting
the consumption of the study product:
- 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.
- Satiety, fullness, hunger, prospective food consumption measured from
baseline until 120 minutes after starting the consumption of the study product.:
- AUC [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 10
minutes relative to 1 serving [%].
- Compliance to use of the study product, defined as volume consumed within 10
minutes relative to 1 serving [%]
- Overall liking of the study product, assessed 10 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. It is most commonly found in association with disease and can affect
all age groups, from older adults to young children. It is more common in older
people as they often have several co-morbidities. Oral nutritional supplements
(ONS) have proven clinical benefits for malnourished patients since its 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 aging is a reduced appetite and/or food intake in old age. One of
the underlying mechanisms for this involves changes in gastrointestinal
motility, resulting in early/postprandial satiety. Test product L-arginine en
L-glutamate can promote gastric emptying and relaxation of the stomach and
therefore reduces the increased feeling of fullness.
Study objective
During the study, the effects of the test product in ONS are examined:
* Test product l-Arginine and l-Glutamate as separate amino acids that are
combined
This study examines the effects of adding the test product in ONS when compared
to the ONS alone.
It is also investigated whether extra fibres in ONS have an effect on the
feeling of satiety and appetite of subjects.
Study design
This is a randomized, controlled, single blind, monocentric, crossover study.
Given the large inter-individual variability in eating behavior and perceptions
of subjective appetite, a cross-over design is chosen for this study. This
design is particularly suitable for comparing the Test Product and Control
Product, which is the primary objective of this study.
Intervention
he subjects are randomized to 1 of the 4 study arms on the basis of a
randomization list.
In each study arm, participants receive 1 amount of a sip feed during the 4
visit days.
The sip feeds consumed are:
* Testproduct: ONS Compact Protein + amino acids L-Arginine en L-Glutamate
* Control product: ONS Compact Protein
* Control product: ONS Compact Fibre + added proteins
* Control product: ONS Compact Fibre + amino acids L-Arginine en L-Glutamate +
added proteins
Every participant consumes the same sip feeds. Only in a different sequence
according to the designated order in the randomization list.
Study burden and risks
The burden on the participants is minimal. The older adults have no specific
condition or indication and the study participation is voluntary.
The expected risks associated with the study product are minimal. The
participants are asked to visit the site 4x to consume the ONS with or without
the test product and to complete subject questionnaires at fixed time points
for +/- 2.5 hours per study visit.
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. Able to consume high energy and/or high protein ONS at discretion of the
Investigator
3. Written informed consent
4. Willing and able to refrain from smoking during the visits
5. Able to speak and read in Dutch to communicate with the site staff and
comply with the instructions and requirements of the study.
Exclusion criteria
1. Any known condition that interferes with the gastric emptying (e.g.,
gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple
sclerosis, Parkinson disease).
2. Any known metabolic condition that interferes with the breakdown of amino
acids (e.g. arginase deficiency, urea cycle disorder)
3. Known history of gastric surgery e.g. (partial) gastrectomy or any other
procedure for stomach volume reduction, including gastric banding, gastric
balloon.
4. Known chronic/continuous use, and/or within 24-48h before the visit, of
medication that strongly affects with gastric emptying or gastric acid
secretion (e.g., metoclopramide, opioid analgesics, calcium channel blockers,
Beta-Adrenergic Receptor Agonists, H2 receptor antagonists, proton pump
inhibitors; tricyclic antidepressants such as amitriptyline, imipramine,
systemic steroids)
5. Known active cancer treatment 4 weeks prior the study start
6. Body Mass Index >= 30.0 kg/m²
7. Presence of Diabetes Mellitus (self-reported or the use of Diabetes
medication: i.e., insulin, biguanides, DPP-4 inhibitors, GLP-1 receptor
agonists)
8. 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
9. Known renal dysfunction with protein restriction diet
10. Known allergy to cow*s milk protein
11. Known allergy to soy
12. Known galactosaemia
13. Known lactose intolerance
14. Excessive alcohol consumption (use of > 14 units per week for women or > 21
units per week for men, on average during the past 6 months).
15. Drug abuse based on investigator*s judgement.
16. Any contraindication to oral feeding per se being: any degree of dysphagia,
gastrointestinal failure or suppressed gastrointestinal function, complete
intestinal obstruction and major intra-abdominal sepsis.
17. Enrolment in any other studies involving investigational or marketed
products concomitantly or within two weeks prior to baseline
18. Employees, family members or other relatives of employees of the
participating centre or of Danone Global Research & Innovation Center.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06645184 |
| CCMO | NL87151.056.24 |