Primary Objective: To investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. Secondary Objective: To investigate the difference in cellular stress response and weight regain after rapid…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The association between the amount of weight regain after the weight loss
period and changes in adipokines, parameters of adipocyte metabolism, in vivo
adipose tissue metabolism, adipocyte extracellular matrix gene expression
profiles, adipocyte stress protein expression and gene polymorphisms in
selected genes.
Secondary outcome
The difference in weight regain and associated parameters between rapid and
slow weight loss regimens.
Background summary
Almost half of the Dutch population is currently characterized by overweight
and obesity. Losing weight is not the problem in obesity treatment, it is the
seemingly obligatory weight regain after weight loss: the yoyo-effect. We
hypothesize that weight loss-induced cellular stress in adipocytes leads to
production of signals by the stressed adipocyte that counteract their stress by
changing metabolism and caloric intake, resulting in weight regain.
Study objective
Primary Objective: To investigate the association between the
weight-loss-induced cellular stress response and the rate of weight regain.
Secondary Objective: To investigate the difference in cellular stress response
and weight regain after rapid and slow weight loss.
Study design
This is a randomized parallel-group human intervention study, comparing to
weight loss interventions.
Intervention
Subjects will receive meal replacements, replacing either all or part of the
daily meals, during the intervention period. The first group will consume a 500
kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for
3 months, both followed by 1 week normalization and a 2 week strict weight
maintenance diet. During the 9 month follow-up period subjects will receive
dietary advice according to the Dutch recommendations for healthy eating.
Study burden and risks
Subjects will follow an energy-restricted diet for 5 weeks to 3 months and will
undergo a number of tests with minor risks. To assess adipose tissue PO2 a
microdialysis probe will be inserted in the anesthetized subcutaneous adipose
tissue two times. Furthermore, a radioactive tracer (13Xe) will be injected to
assess adipose tissue blood flow, with a radioactivity that is equal to about
one-fiftieth the amount of a chest x-ray (four times). Also, fat percentage
will be measured using the Bod Pod. Throughout the study, ten breath samples
will be collected in a 5 liter plastic bag. These measurements are completely
painless and will take about 5 minutes . In vivo adipose tissue metabolism will
be studied after ingestion of a high-fat meal enriched with a stable isotope
tracer ( [U-13C] palmitic acid) (2 times). This technique also requires the
cannulation of an epigastric vein and a superficial dorsal hand vein. Adipose
tissue biopsies are taken from the abdominal subcutaneous adipose tissue by an
experienced researcher at Maastricht University (4 times). The biopsies will be
collected under local anaesthesia using the needle biopsy technique. A total
volume of 770 ml blood will be collected during the entire study period of
11-13 months. Finally, subjects will complete habitual physical activity
questionnaires and 3-day food diaries (4 resp 3 times). Subjects will
potentially benefit from this study via a reduction in risk factors for
cardiovascular diseases due to weight loss. In addition they will receive
advice on healthy eating habits from a dietician.
Universiteitssingel 50
Maastricht 6200 MD
NL
Universiteitssingel 50
Maastricht 6200 MD
NL
Listed location countries
Age
Inclusion criteria
healthy volunteers aged 20-65 y, BMI 28-35 kg/m2, non-smokers
Exclusion criteria
Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1), marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female), planned major changes in physical activity during the study to an extent that might interfere with the study outcome, as judged by the investigator; blood donation within the past 2 months prior to the study; weight change of >3 kg within 2 months prior to the study; psychiatric disease (based on medical history only); pregnant or lactating women, or women planning to become pregnant within the next 12 months; surgically treated obesity; participation in other clinical studies within the last 3 months; drug abuse (based on clinical judgment); unable to give informed consent; unable to engage in a low-calorie diet; following a special diet (e.g. Atkins).
Design
Recruitment
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL38099.068.11 |