An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect

Maastricht University Medical Center1 site in 1 country58 target enrollmentMarch 2012

ConditionsObesity Weight Loss Diet

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Maastricht University Medical Center
Enrollment: 58
Locations: 1
Primary Endpoint: change in weight following weight loss
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 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. 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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

November 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age (years): 20-65
•Body Mass Index (kg/m2): 28-35
•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)

Outcomes

Primary Outcomes

change in weight following weight loss

Time Frame: at 16 weeks and at 53 weeks

LCD diet group

Secondary Outcomes

change in adipokine during weight stable-period (VLCD-group)(after 5 weeks of VLCD diet and after 9 weeks)
change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in adipokine profile due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in adipokine profile during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in adipokine profile due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in adipokine profile during follow-up (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in adipokine profile in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in parameters of adipocyte fat metabolism during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
change in adipokine profile during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
Changes in adipokine profile in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group)(at 9 weeks and after follow-up period at 46 weeks)
change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in breath volatile organic compounds during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in physiological parameters due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in in-vivo adipose tissue metabolism during follow-up period (LCD-group)(at 16 weeks and after follow-up period at 53 weeks)
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in physiological parameters during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in physiological parameters during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
Changes in physiological parameters in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in adipocyte stress proteins expression during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in physiological parameters due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in physiological parameters during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
change in plasma metabolic parameters due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in fat cell size and fat cell number during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in fat cell size and fat cell number during follow-up period (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in adipocyte stress proteins expression during follow-up period (VLCD-group)(at 9 weeks and after follow-up period at week 46)
change in adipocyte stress proteins expression due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in adipocyte stress proteins expression in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group)(at 9 weeks and after follow-up period at 46 weeks)
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group)(at 16 weeks and after follow-up period)
change in adipocyte stress proteins expression due to dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in adipocyte stress proteins expression during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at week 16)
change in physiological parameters during follow-up period (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in plasma metabolic parameters during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in fat cell size and fat cell number during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in inflammatory parameters during follow-up period (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in protein concentration of metabolic parameters during follow-up (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in protein concentration of metabolic parameters during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in adipocyte stress proteins expression during follow-up period (LCD-group)(at week 16 and after follow-up period at 53 weeks)
change in plasma metabolic parameters due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in plasma metabolic parameters during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
Changes in plasma metabolic parameters in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in fat cell size and fat cell number due to the dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in fat cell size and fat cell number due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
Changes in fat cell size and fat cell number in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in breath volatile organic compounds during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
Changes in breath volatile organic compounds in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in protein concentration of metabolic parameters during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
change in protein concentration of metabolic parameters in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
Changes in physiological parameters in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in plasma metabolic parameters during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in plasma metabolic parameters during follow-up period (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in fat cell size and fat cell number during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
change in breath volatile organic compounds due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
Changes in protein concentration of metabolic parameters due to the dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in protein concentration of metabolic parameters due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
Changes in plasma metabolic parameters in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
Changes in fat cell size and fat cell number in relation to weight regain after weight loss(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in breath volatile organic compounds due to the dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in breath volatile organic compounds during follow-up period (VLCD-group)(at 9 weeks and after follow-up at 46 weeks)
change in breath volatile organic compounds during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
Changes in breath volatile organic compounds in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
change in inflammatory parameters due to the dietary intervention (VLCD-group)(at baseline and after 5 weeks of VLCD diet)
change in inflammatory parameters during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in inflammatory parameters due to dietary intervention (LCD-group)(at baseline and after 12 weeks of LCD diet)
change in inflammatory parameters during weight-stable period (LCD-group)(after 12 weeks of LCD diet and at 16 weeks)
change in inflammatory parameters during follow-up (LCD-group)(at 16 weeks and after follow-up at 53 weeks)
Changes in inflammatory parameters in the LCD-group compared to the VLCD-group(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
Changes in inflammatory parameters in relation to weight regain during the follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)
Changes in protein concentration of metabolic parameters during weight-stable period (VLCD-group)(after 5 weeks of VLCD diet and at 9 weeks)
change in protein concentration of metabolic parameters in relation to weight regain during follow-up(at baseline, at 5, 9, 12, 16, 46 and 53 weeks)