To determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.
ID
Source
Brief title
Condition
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are energy expenditure, substrate oxidation
and sleep.
Secondary outcome
The secondary endpoints of this study are body composition, fat distribution,
muscle protein synthesis rate, expressed as fractional synthetic rate (FSR) and
whole body protein turnover.
Background summary
The prevalence of obesity has increased worldwide to epidemic proportions. For
long-term treatment success permanent lifestyle changes are necessary with
regard to approach to food, physical activity patterns and behavior to
emotional stress. Moreover, an association has been shown between sleep
disturbance and obesity.
Weight loss strategies regarding food intake regulation mainly focused on
changing patterns of fat and carbohydrate consumption during the last decades.
The role of protein has largely been ignored. However, protein has been
observed to increase satiety and energy expenditure to a greater extent than
carbohydrate and fat and can therefore reduce energy intake. However, it still
has to be confirmed if this effect is permanent or transient over a longer
period of time. Moreover, dietary intakes may significantly affect sleep when
macronutrient intakes are manipulated. Since sleep deprivation has been
recognized as a risk factor for obesity, improving sleep by a change in
macronutrient intake would be promising in the treatment of obesity.
Study objective
To determine energy expenditure and sleep in response to protein/carbohydrate
and fat ratio of the diet over a short-term and long-term period of time.
Study design
The study will be conducted in a parallel design. Allocation of subjects to the
two conditions is randomized.
Intervention
The subjects will stay three times 48 hours in the respiration chamber: at
baseline, after 1 week (short-term effect) and after 12 weeks (long-term
effect) of dietary intervention. After baseline (protein intake of 15 En%), two
conditions will be applied: protein intake of 5 and 30 energy percent. Fat
content will be kept constant.
Study burden and risks
This study does not include major risk factors for the subjects. Blood sampling
in this study is limited and without side effects, except from a minor risk of
bruising. Deuterium is an isotope of water that naturally appears in the body.
Drinking it does not expose the subject to any risks. Urine sampling will be
done in urine bottles added with diluted HCl, which might pose a risk for the
subjects. However, subjects will be carefully instructed on how to handle the
bottles to reduce these risks. Additionally, there are no risks for the subject
in consuming any of the provided meals, because people with certain food
allergies are excluded for participation and all food items will be
commercially available in normal Dutch supermarkets. A 30En% protein or a 5En%
protein diet for 12 weeks will not have any side effects on the subject*s
health. Studies in the respiratory chamber will be conducted using standard
operating procedures. A pair of subjects will always participate in the study
at the same time and therefore they will never be alone. The subjects will be
able to contact the investigators during the entire night. In addition, they
will be able to get out of the chamber at any time they feel uncomfortable. The
experiment will take about 162 hours of the subject*s time. Insertion of the
catheters in a vein is comparable to venapunction and here as well the only
risk is a small local hematoma. This is the same for the muscle biopsy. The
incision made for obtaining the muscle biopsy will be done by an experienced
physician and will heal completely. The research group of Prof. Dr. L. van Loon
has extensive experience with taking muscle biopsies. During the follow up
several days after taking the biopsy no complications have been reported.
The test beverages contain tested normal nutritional ingredients and for this
reason do not form any health risks. The labeled amino acids tracers applied in
this experiment are not radioactive and are completely safe. The production of
the tracers for intravenous administration will occur in a sterile environment
according to GMP guidelines.
This study does not have any benefits for the subjects themselves, but will
give possible new knowledge for the treatment of obesity.
Universiteitssingel 50
Maastricht 6200 MD
NL
Universiteitssingel 50
Maastricht 6200 MD
NL
Listed location countries
Age
Inclusion criteria
Healthy, age 18-35 y, BMI 18-27 kg/m2, non-smoking, weight stable, no sleeping problems, estimated glomerular filtration rate >= 90ml/min/1.73m2
Exclusion criteria
Smoking, use of medication, sleep problems, more than moderate alcohol consumption, estimated glomerular filtration rate < 90ml/min/1.73m2
Exclusion criteria for MRI (electronic implants, pacemakers, metal fragments in the eyes, skin or body)
For muscle protein synthesis measurement, all co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis), use of anticoagulants, blood diseases, allergy for lidocain, use of gastric acid inhibitors.
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 |
|---|---|
| ClinicalTrials.gov | NCT01551238 |
| CCMO | NL39152.068.11 |