No registrations found.
ID
Source
Brief title
Health condition
Healthy older subjects (age 65 years or older)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the time to reach half incremental area under the curve (t½ iAUC) for the sum of all amino acids (total AA) comparing product A to product B.
Secondary outcome
The secondary outcome parameters of this study are:
• The (incremental) maximum amino acid concentration ((i)Cmax), (incremental) area under the concentration curve ((i)AUC) and t½ iAUC comparing all study products for total AA
• Gastric emptying half time (t1/2), Cmax, and time until Cmax is reached (Tmax) and AUC (plasma concentrations of paracetamol) comparing all study products
• Satiety questionnaire
Background summary
The purpose of the current study is to gain knowledge regarding amino acid bioavailability of different proteins and protein mixes.
Secondly, we aim to study the impact of different proteins on gastric emptying and postprandial fullness and satiety.
This is a randomized, controlled, double-blind, crossover, single-centre study which aims to include 13 healthy older subjects (age 65 years or older) with a minimum of 4 subjects for each sex.
Six different study products will be investigated:
- 4 seperate proteins
- two mixes of these proteins
Study objective
The administered protein mix is related to a faster postprandial amino acid bioavailability compared to a single protein as measured by the t½ of the iAUC.
Study design
Time points of the outcome: V1 (baseline) until V6 (week 6).
Intervention
Duration of intervention: 5 weeks
Intervention group: 5 weeks
Control group: 5 weeks
Zandrie Hofman
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31-30-2095000
zandrie.hofman@danone.com
Zandrie Hofman
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31-30-2095000
zandrie.hofman@danone.com
Inclusion criteria
1. Age 65 years or older
2. BMI from 20 through 30 kg/m2
3. Willingness and ability to comply with the protocol
4. Written informed consent
5. Be judged by the investigator to be in good health
Exclusion criteria
1. Any gastrointestinal (GI) disease or surgery that interferes with GI function
2. Known renal or hepatic failure
3. Known or suspected Diabetes Mellitus (fasting glucose level ¡Ý 7.0 mmol/L)
4. (History of) any cancer with the exception of basal cell carcinoma
5. Fever in the last 7 days prior to Visit 1
6. Haemoglobin in men <7.5 mmol/L and in women <7.0 mmol/L
7. Use of antibiotics, or anticonvulsants, or prokinetics, or antacids or any medication influencing gastric acid production, or oral and systemic use of anticoagulants, or corticosteroids, or laxatives, or growth hormone, or testosterone, or immunosuppressants or insulin within 3 weeks of Visit 1
8. Known severe weight loss (> 3 kg in last 3 months)
9. Participation to a weight loss program
10. Use of protein containing or amino acid containing nutritional supplements within one week of Visit 1
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 |
|---|---|
| NTR-new | NL5311 |
| NTR-old | NTR5420 |
| Other | : NTS.1.P/H, Nutricia Research B.V. |