The primary objective of this study is to evaluate tolerance of a new high-energy high-protein oral nutritional supplement compared to a commercially available high-energy high-protein oral nutritional supplement in elderly subjects in need of oral…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter is tolerance. Tolerance will be evaluated by measuring
the following parameters:
- Daily stool frequency and consistency
- Tolerance questionnaire
Secondary outcome
The secundairy parameters are safety and intake. These will be evaluated by
measuring the following parameters:
- Daily study product intake
- Fluid intake
- Occurrence of (Serious) Adverse Events
- Blood parameters
- Urine parameters
- Paramters derived from blood and urine parameters
- Blood pressure
- Resting heart rate
Other parameters are:
- Body weight
- Body Mass Index
- Dietary Intake
- Product appreciation (for example taste).
Background summary
Many people of 65 years and older who suffer from unwanted weightloss are
prescribed with oral nutritional supplement to supplement their normal food
intake. Often they find it hard to completely consume the prescribed amount of
oral nutritional supplement. Danone Research has developed a new high-energy
high-protein oral nutritional supplement, specifically for people who can not
or do not want to drink large volumes of oral nutritional supplement.
Study objective
The primary objective of this study is to evaluate tolerance of a new
high-energy high-protein oral nutritional supplement compared to a commercially
available high-energy high-protein oral nutritional supplement in elderly
subjects in need of oral nutritional support.
The secondary objectives of this study are to evaluate intake and safety of a
new high-energy high-protein oral nutritional supplement compared to a
commercially available high-energy high-protein oral nutritional supplement in
elderly subjects in need of oral nutritional support.
Study design
Randomised, controlled, single blind, parallel-group, multi-country study.
Intervention
One group receives daily at least 1 bottle of the new high-energy high-protein
oral nutritional supplement, the other group receives daily at least 1 bottle
of the standard high-energy high-protein oral nutritional supplement. The
amount of bottles per day depends on what has been prescribed by the healthcare
professional.
Study burden and risks
The burden for subjects is small and the expected risks are limited.
The burden for the subjects will be:
- Daily study product intake for 8 weeks
- 4 x completion of tolerance questionnaire
- 4 x completion of product appreciation questionnaire
- 3 x blood collection (with a chance for locale bleeding and/or pain due to
the venapunction)
- 3 x urine collection
- 3 x measuring of the blood pressure
- 3 x measuring of the resting heart rate
The adverse events that might result from the new high-energy high-protein oral
nutritional supplement are expected to be mild and acceptable for the study
population. From the control product (the standard high-energy high-protein
oral nutritional supplement) no adverse events are expected.
Postbus 7005
6700 CA Wageningen
NL
Postbus 7005
6700 CA Wageningen
NL
Listed location countries
Age
Inclusion criteria
1. Male/female subjects >= 65 years of age
2. Subject is in need of oral nutritional support of >= 300 kcal/day
3. Subject is expected to require oral nutritional support for at least 8 weeks
4. Subject has given written informed consent
5. Subject is able to comply with the protocol (e.g. answer questions, collect urine)
Exclusion criteria
1. Known inflammatory bowel disease (e.g. Crohn*s disease)
2. Known lactose intolerance and not using lactase
3. Known galactosaemia
4. Known cow*s milk allergy
5. Known major hepatic dysfunction: symptomatic hepatic dysfunction or previous serum transaminase (ALAT, ASAT, or alkaline phosphatase) levels more than 5 times upper limit of normal
6. Known renal dysfunction: symptomatic renal dysfunction or a previous GFR < 60 mL/min/1.73 m2 for longer than 3 months (stage 3 - stage 5 chronic kidney disease)
7. Requirement of a protein restricted diet (such as for renal failure)
8. Ileostomy or colostomy
9. Parenteral feeding
10. Tube feeding
11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
12. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
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 |
|---|---|
| CCMO | NL34478.072.10 |