The main objective of the present project is to assess the impact of gender, physical inactivity, obesity, and bariatric bypass surgery on basal and postprandial muscle protein synthesis rates. This will be investigated by means of three different…
ID
Source
Brief title
Condition
- Other condition
- Gender related factors
- Gastrointestinal therapeutic procedures
Synonym
Health condition
inactiviteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint for all studies: Basal and postprandial muscle protein
synthesis rates, expressed as fractional synthetic rate (FSR).
Secondary outcome
Secondary endpoints: Rate of protein digestion and absorption.
Background summary
The loss of muscle mass with aging is accompanied by reduced physical
performance, loss of functional capacity, increased risk of falling and
increased likelihood of developing chronic metabolic diseases, such as type 2
diabetes and obesity. Basal and postprandial muscle protein synthesis are key
determinants for the maintenance of muscle mass. Besides aging, basal and
postprandial muscle protein synthesis may be strongly affected by other
important factors, including gender, physical inactivity and obesity.
Study objective
The main objective of the present project is to assess the impact of gender,
physical inactivity, obesity, and bariatric bypass surgery on basal and
postprandial muscle protein synthesis rates. This will be investigated by means
of three different studies.
Study A: The impact of gender on basal and postprandial muscle protein
synthesis.
Study B: The impact of physical inactivity on basal and postprandial muscle
protein synthesis.
Study C: The impact of obesity and bariatric bypass surgery on basal and
postprandial muscle protein synthesis.
Study design
Study A: cross-sectional study of basal and postprandial muscle protein
synthesis.
Study B: experimental intervention study design, with measurements of basal and
postprandial muscle protein synthesis after 5 days of unilateral knee
immobilization.
Study C: single group pretest-posttest study design, with measurements of basal
and postprandial muscle protein synthesis before and 6 months after bariatric
bypass surgery.
Intervention
Study 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 whey protein. Blood plasma samples
and muscle biopsies will be collected during the test day.
Study 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 whey protein. Blood plasma samples
and muscle biopsies will be collected during the test day.
Study 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 whey protein. Blood plasma samples
and muscle biopsies will be collected during the test day. The test day will be
repeated 6 months after bariatric bypass surgery.
Study burden and risks
Study A, B, and C: Insertion of the catheters in a vein is comparable to a
normal blood draw and the only risk is a small local hematoma. This is the same
for the muscle biopsies. Muscle biopsies will be taken through a small (5 mm)
incision, following local anaesthetics of the skin and muscle fascia, and will
heal completely. Muscle biopsies will only be obtained by an experienced
physician. The test beverages contain intrinsically labelled dietary protein
which is safe for human consumption and which have been used in previous
studies (METC 06-3-064, METC 07-3-086, METC 09-3-078, METC-11-3-040, METC
11-3-057). The labelled, non-radioactive amino acids tracers that will be
infused intravenously are produced according to GMP standards and are
completely safe.
Study B: Five days of limb immobilization via a full leg cast will impair
subject*s mobility for this period. However, to minimize any risk of injury
subjects will not be allowed to drive a vehicle or ride a bicycle and will have
daily contact with the investigators. The expected loss of muscle mass and
strength following immobilization will be rapidly (<2 weeks) regained due to
the inclusion of healthy volunteers.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Substudy A:
-Normal weight (BMI 19-25 kg/m2)
-Middle-aged (age 30-55 yrs);Substudy B:
-Males
-Young to middle-aged (18-35 yrs);Substudy C:
-Males
-Middle-aged (30-55 yrs)
-Extreme obesity (BMI >35 kg/m2)
-Scheduled for bariatric bypass surgery
Exclusion criteria
Substudy 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, NSAID*s) 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).
- Participation in regular exercise for >3 week or >150 min/week.
- Type 2 diabetes (according to OGTT).;Substudy B:
- Currently smoking cigarettes or tobacco
- Allergies to milk proteins (whey or casein)
- Arthritic conditions
- A history of neuromuscular problems
- Diagnosed impaired renal or liver function
- 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, NSAID*s) 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).
-History with deep venous thrombosis or pulmonary embolie.
-Participation in regular exercise for >3 week or >150 min/week.
-Type 2 diabetes (HbA1c>6.5%).;Substudy C:
- Allergies to milk proteins (whey or casein)
- A history of neuromuscular problems
- Diagnosed impaired renal or liver function
- 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).
- Participation in regular exercise for >3 week or >150 min/week.
- Diagnosed type 2 diabetes, and/or use of blood glucose lowering medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42551.068.12 |
| OMON | NL-OMON23856 |