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

NCT01559415 | Completed

• 1 other identifier: 38099
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• change in weight following weight loss

  VLCD diet group

  at 9 weeks and at 46 weeks

• change in weight following weight loss

  LCD diet group

  at 16 weeks and at 53 weeks

Secondary Outcomes (88)

• change in adipokine profile due to dietary intervention (VLCD-group)

  at baseline and after 5 weeks of VLCD diet

• change in adipokine during weight stable-period (VLCD-group)

  after 5 weeks of VLCD diet and after 9 weeks

• change in adipokine profile during follow-up (VLCD-group)

  at 9 weeks and after follow-up at 46 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 weight-stable period (LCD-group)

  after 12 weeks of LCD diet and at 16 weeks

Study Arms (2)

Very Low Calorie Diet

EXPERIMENTAL

Other: Meal replacement diet using Modifast

Low Calorie Diet

ACTIVE COMPARATOR

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

Other: Normal diet combined with Modifast diet

Interventions

Meal replacement diet using Modifast OTHER

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

Very Low Calorie Diet

Normal diet combined with Modifast diet OTHER

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

Low Calorie Diet

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 35366329 DERIVED

• 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.

  PMID: 32015415 DERIVED

• 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.

  PMID: 29399976 DERIVED

• 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.

  PMID: 28639346 DERIVED

• 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.

  PMID: 28298393 DERIVED

• 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.

  PMID: 28179648 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Marleen van Baak, Professor

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 21, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

NL (1)