No registrations found.
ID
Source
Brief title
Health condition
Sarcopenia
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the Leucine Cmax [μmol/L] (product A compared to product B).
Secondary outcome
The secondary outcome parameters in this study are comparison of product A and B on:
• Leucine iCmax [μmol/L], iAUC [μmol/L*min] and t½ iAUC [min]
• Essential aminoacids Cmax [μmol/L], iCmax [μmol/L], iAUC [μmol/L*min] and t½ iAUC [min]
• Total sum aminoacids Cmax [μmol/L], iCmax [μmol/L], iAUC [μmol/L*min] and t½ iAUC [min]
• Adverse events and (Gastro-Intestinal) tolerance questionnaire
Background summary
In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.
Study objective
The amino acid bioavailability of the Test Product is equivalent to Comparator Product 1
Study design
Time points of the outcome: every study visit (V1 to V4)
Intervention
Duration of intervention: 4 weeks
Intervention and Control group:
Subjects will be randomised into one of four groups:
Group I: receiving product A, B, C and D in visit 1, 2, 3 and 4 respectively
Group II: receiving product A, B, D and C in visit 1, 2, 3 and 4 respectively
Group III: receiving product B, A, C and D in visit 1, 2, 3 and 4 respectively
Group IV: receiving product B, A, D and C in visit 1, 2, 3 and 4 respectively
PO Box 80141 <br>
3508 TC Utrecht
Carolien Buurman
Uppsalalaan 12
Utrecht
The Netherlands
+31 30 209 50 00
carolien.buurman@danone.com
PO Box 80141 <br>
3508 TC Utrecht
Carolien Buurman
Uppsalalaan 12
Utrecht
The Netherlands
+31 30 209 50 00
carolien.buurman@danone.com
Inclusion criteria
1. Age 65 years or older
2. BMI from 20 through 30 kg/m2
Exclusion criteria
1. Any gastrointestinal (GI) disease that interferes with GI function
2. Known renal or hepatic failure
3. Known or suspected Diabetes Mellitus (fasting glucose level ≥ 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, corticosteroids, growth hormone, testosterone, immunosuppressants or insulin within 3 weeks of Visit 1
8. Known severe weight loss (> 3 kg in last 3 months)
9. Adherence to a weight loss programme
10. Use of protein containing or amino acid containing nutritional supplements within one week of Visit 1
11. Current or recent (within past 3 months) smoking
13. Known allergy to the ingredients of the study products
14. Known galactosaemia
15. Blood donation within 2 months of study entry and during 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 |
|---|---|
| NTR-new | NL4012 |
| NTR-old | NTR4184 |
| Other | Nutricia Research : Spa.1.C.D.34 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |