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)


The impact of gender, inactivity, and obesity on muscle mass building and muscle mass maintenance.


- candidate number15071
- NTR NumberNTR4060
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jul-2013
- Secondary IDsNL42551.068.12 METC 12-3-063
- Public TitleThe impact of gender, inactivity, and obesity on muscle mass building and muscle mass maintenance.
- Scientific TitleThe impact of gender, inactivity, and obesity on basal and postprandial muscle protein synthesis.
- ACRONYMThe GIO study
- hypothesis1. The postprandial muscle protein synthesis rate is smaller in females as compared with males.
2. Short-term physical inactivity reduces basal and postprandial muscle protein synthesis rates.
3. Basal and postprandial muscle protein rates are blunted in obese as compared to lean individuals.
- Healt Condition(s) or Problem(s) studiedAging, Inactivity, Overweight, Gender, Muscle protein synthesis
- Inclusion criteriaSubgroup A:
-Males and females
-Aged between 30-55 years
-BMI 19-25 kg/m2


Subgroup B:
-Male
-Aged between 18-35 years
-BMI 19-30 kg/m2


Subgroup C:
-Male
-Aged between 30-55 years
-BMI >35 kg/m2
- Exclusion criteriaSubgroup A:
-Currently smoking cigarettes or tobacco
-Allergies to milk proteins (whey or casein)
-A history of neuromuscular problems
-Diagnosed impaired renal (kidney stones, nephritis, nephritic syndrome, end-stage renal disease) or liver function (acute or chronic hepatitis, alcoholic liver disease, liver cirrhosis)
-Use of medications known to affect digestion and/or absorption (antacids, H-2-receptor blockers, proton pump inhibitors, NSAIDís) 7 days prior to the experimental test-day.
-Use of anticoagulants, blood diseases, allergy for lidocain
-Use of medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or acne medications).
-Type 2 diabetes (exclusion when: fasting glucose level >7.0 mmol/L, or 2-h glucose level>11.1 mmol/l, or HbA1c >6.5%.

Subgroup B:
-Currently smoking cigarettes or tobacco
-Allergies to milk proteins (whey or casein)
-Arthritic conditions
-History of neuromuscular problems
-History of deep venous thrombosis (DVT) or pulmonary emboli (PE).
-Diagnosed impaired renal (kidney stones, nephritis, nephritic syndrome, end-stage renal disease) or liver function (acute or chronic hepatitis, alcoholic liver disease, liver cirrhosis)
-Use of medications known to affect digestion and/or absorption (antacids, H-2-receptor blockers, proton pump inhibitors, NSAIDís) 7 days prior to the experimental test-day
-Use of anticoagulants, blood diseases, allergy for lidocain
-Use of medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or acne medications).
-Type 2 diabetes (HbA1c >6.5%).

Subgroup C:
-Allergies to milk proteins (whey or casein)
-A history of neuromuscular problems
-Diagnosed impaired renal (kidney stones, nephritis, nephritic syndrome, end-stage renal disease) or liver function (acute or chronic hepatitis, alcoholic liver disease, liver cirrhosis)
-Use of anticoagulants, blood diseases, allergy for lidocain
-Use of medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or acne medications).
-Diagnosed type 2 diabetes, and/or use of blood glucose lowering medication.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-mrt-2015
- Target number of participants62
- InterventionsSubstudy A: During a single test day, subjects will undergo continuous intravenous tracer infusions of labelled amino acids, and subjects ingest a beverage containing 25 gram intrinsically labelled milk protein. Blood plasma samples and muscle biopsies will be collected during the test day.

Substudy B: Five days of unilateral knee immobilization will be followed by a single test day. During the test day, subjects undergo continuous intravenous tracer infusions of labelled amino acids, and subjects ingest a drink containing 25 gram intrinsically labelled milk protein. Blood plasma samples and muscle biopsies will be collected during the test day.

Substudy C: During a single test day, subjects undergo continuous intravenous tracer infusions of labelled amino acids, and subjects ingest a drink containing 25 gram intrinsically labelled milk protein. Blood plasma samples and muscle biopsies will be collected during the test day.
- Primary outcomeBasal and postprandial muscle protein synthesis rates.
- Secondary outcomeRate of protein digestion and absorption.
- TimepointsSubjects participate in a screening session and a single test day. During the test day, frequent blood samples and muscle biopsies will be taken for the assessment of basal and postprandial muscle protein synthesis. Basal muscle protein synthesis will be assessed over a 2-hour period, and postprandial muscle protein synthesis will be assessed over a 5-hour period.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jan-Willem Dijk, van
- CONTACT for SCIENTIFIC QUERIES Luc Loon, van
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Food & Nutrition
- PublicationsN/A
- Brief summaryThe main objective of the present project is to assess the impact of gender, physical inactivity, and obesity on basal and postprandial muscle protein synthesis rates. This will be investigated in three different substudies:

Substudy A: The impact of gender on basal and postprandial muscle protein synthesis.
Substudy B: The impact of physical inactivity on basal and postprandial muscle protein synthesis.
Substudy C: The impact of obesity on basal and postprandial muscle protein synthesis.

Basal and postprandial muscle protein synthesis will be studies by means of stable isotope methodology and intrinsically labeled milk proteins.
- Main changes (audit trail)
- RECORD4-jul-2013 - 21-jul-2013


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