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

NCT ID: NCT01559415

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-11-30

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.

Conditions

Obesity; Weight Loss; Diet

Keywords

Adipocytes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Very Low Calorie Diet

Group Type: EXPERIMENTAL

Meal replacement diet using Modifast

Intervention Type: OTHER

modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks

Low Calorie Diet

1250 kcal diet in which Modifast is given in combination with a normal diet

Group Type: ACTIVE_COMPARATOR

Normal diet combined with Modifast diet

Intervention Type: OTHER

Combination of modifast and regular diet (1250 kcal/d) for 3 months

Interventions

Meal replacement diet using Modifast

modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks

Intervention Type: OTHER

Normal diet combined with Modifast diet

Combination of modifast and regular diet (1250 kcal/d) for 3 months

Intervention Type: OTHER

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)
• unable to give informed consent
• unable to engage in a low-calorie diet
• unable to lose more then 8% of body weight after weight-loss period
• following a special diet (vegetarian, Atkins or other).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marleen van Baak, Professor

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

Qiao Q, Bouwman FG, van Baak MA, Roumans NJT, Vink RG, Mariman ECM. Plasma Levels of Triglycerides and IL-6 Are Associated With Weight Regain and Fat Mass Expansion. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1920-1929. doi: 10.1210/clinem/dgac198.

Reference Type: DERIVED

PMID: 35366329 (View on PubMed)

Tareen SHK, Kutmon M, de Kok TM, Mariman ECM, van Baak MA, Evelo CT, Adriaens ME, Arts ICW. Stratifying cellular metabolism during weight loss: an interplay of metabolism, metabolic flexibility and inflammation. Sci Rep. 2020 Feb 3;10(1):1651. doi: 10.1038/s41598-020-58358-z.

Reference Type: DERIVED

PMID: 32015415 (View on PubMed)

Roumans NJT, Wang P, Vink RG, van Baak MA, Mariman ECM. Combined Analysis of Stress- and ECM-Related Genes in Their Effect on Weight Regain. Obesity (Silver Spring). 2018 Mar;26(3):492-498. doi: 10.1002/oby.22093. Epub 2018 Feb 5.

Reference Type: DERIVED

PMID: 29399976 (View on PubMed)

Vink RG, Roumans NJ, van der Kolk BW, Fazelzadeh P, Boekschoten MV, Mariman EC, van Baak MA. Adipose Tissue Meal-Derived Fatty Acid Uptake Before and After Diet-Induced Weight Loss in Adults with Overweight and Obesity. Obesity (Silver Spring). 2017 Aug;25(8):1391-1399. doi: 10.1002/oby.21903. Epub 2017 Jun 22.

Reference Type: DERIVED

PMID: 28639346 (View on PubMed)

Roumans NJ, Vink RG, Fazelzadeh P, van Baak MA, Mariman EC. A role for leukocyte integrins and extracellular matrix remodeling of adipose tissue in the risk of weight regain after weight loss. Am J Clin Nutr. 2017 May;105(5):1054-1062. doi: 10.3945/ajcn.116.148874. Epub 2017 Mar 15.

Reference Type: DERIVED

PMID: 28298393 (View on PubMed)

Vink RG, Roumans NJ, Cajlakovic M, Cleutjens JPM, Boekschoten MV, Fazelzadeh P, Vogel MAA, Blaak EE, Mariman EC, van Baak MA, Goossens GH. Diet-induced weight loss decreases adipose tissue oxygen tension with parallel changes in adipose tissue phenotype and insulin sensitivity in overweight humans. Int J Obes (Lond). 2017 May;41(5):722-728. doi: 10.1038/ijo.2017.38. Epub 2017 Feb 9.

Reference Type: DERIVED

PMID: 28179648 (View on PubMed)

Other Identifiers

38099

Identifier Type: -

Identifier Source: org_study_id