The amino acid bioavailability of the Test Product is equivalent to Comparator Product 1
ID
Bron
Verkorte titel
Aandoening
Sarcopenia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameter in this study is the Leucine Cmax [μmol/L] (product A compared to product B).<br>
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The amino acid bioavailability of the Test Product is equivalent to Comparator Product 1
Onderzoeksopzet
Time points of the outcome: every study visit (V1 to V4)
Onderzoeksproduct en/of interventie
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
Algemeen / deelnemers
PO Box 80141 <br>
3508 TC Utrecht
Carolien Buurman
Uppsalalaan 12
Utrecht
The Netherlands
+31 30 209 50 00
carolien.buurman@danone.com
Wetenschappers
PO Box 80141 <br>
3508 TC Utrecht
Carolien Buurman
Uppsalalaan 12
Utrecht
The Netherlands
+31 30 209 50 00
carolien.buurman@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 65 years or older
2. BMI from 20 through 30 kg/m2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4012 |
| NTR-old | NTR4184 |
| Ander register | Nutricia Research : Spa.1.C.D.34 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |