search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Amino acid bioavailability in healthy older adults after bolus intake of high protein oral nutritional supplements


- candidate number15453
- NTR NumberNTR4184
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2013
- Secondary IDsSpa.1.C.D.34 Nutricia Research
- Public TitleAmino acid bioavailability in healthy older adults after bolus intake of high protein oral nutritional supplements
- Scientific TitleAmino acid bioavailability in healthy older adults after bolus intake of high protein oral nutritional supplements
- ACRONYMPro-Avail
- hypothesisThe amino acid bioavailability of the Test Product is equivalent to Comparator Product 1
- Healt Condition(s) or Problem(s) studiedSarcopenia
- Inclusion criteria1. Age 65 years or older
2. BMI from 20 through 30 kg/m2
- Exclusion criteria1. 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-nov-2013
- planned closingdate2-apr-2014
- Target number of participants12
- InterventionsDuration 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
- Primary outcomeThe primary outcome parameter in this study is the Leucine Cmax [μmol/L] (product A compared to product B).
- Secondary outcomeThe secondary outcome parameters in this study are comparison of product A and B on:
Leucine iCmax [μmol/L], iAUC [μmol/L*min] and t iAUC [min]
Essential aminoacids Cmax [μmol/L], iCmax [μmol/L], iAUC [μmol/L*min] and t iAUC [min]
Total sum aminoacids Cmax [μmol/L], iCmax [μmol/L], iAUC [μmol/L*min] and t iAUC [min]
Adverse events and (Gastro-Intestinal) tolerance questionnaire
- TimepointsTime points of the outcome: every study visit (V1 to V4)
- Trial web siteNA
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Carolien Buurman
- CONTACT for SCIENTIFIC QUERIES Yvette Luiking
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD24-sep-2013 - 8-okt-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl