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A Low Glycemic Index Diet as Prevention of the Catch-up Fat Phenomenon

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737034
First Posted: November 29, 2012
Last Update Posted: November 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Manfred James Müller, University of Kiel
  Purpose
The catch-up fat phenomenon is an evolutionary conserved physiological response to a starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis, reduced body protein regain and an increase in fat mass above basal level during refeeding. Clinically, it characterises weight cycling in overweight patients which is associated with increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance, inflammation). In this project, the physiological, cellular and molecular mechanisms of this phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat phenomenon and its sequelae. This translational research will provide comprehensive insights into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.

Condition Intervention
Dietary Intervention Other: dietary intervention by varying GI diets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ätiologie, Pathophysiologie Und Prävention Einer überschießenden Körperfettzunahme Nach Gewichtsreduktion - Vermeidung Des JoJo-Effektes in Der Behandlung Von Übergewicht

Further study details as provided by Prof. Dr. Manfred James Müller, University of Kiel:

Primary Outcome Measures:
  • Changes in body composition and energy metabolism after 3 weeks of underfeeding and 2 following weeks of refeeding [ Time Frame: Body composition measurement after 4 and 6 study weeks ]
    Body composition measurement including BODPOD, QMR, BIA Energy Metabolism measurement using indirect calorimetry


Enrollment: 32
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low GI, low GI
low GI diet (semi starvation phase) followed by low GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Experimental: low GI, high GI
low GI diet (semi starvation phase) followed by high GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Experimental: high GI, low GI
high GI diet (semi starvation phase) followed by low GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Experimental: high GI, high GI
high GI diet (semi starvation phase) followed by high GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.

Detailed Description:
In a human intervention study, changes in physiological, metabolic, and neuroendocrine functions in response to weight cycling will be investigated under controlled conditions in normal weight subjects. The mechanisms of the catch-up fat phenomenon are analysed starting from stable energy balance followed by overfeeding, weight loss and weight regain following weight loss (refeeding). Changes in body composition (including ectopic fat), metabolism (resting energy expenditure, substrate oxidation rates, insulin resistance) and plasma hormone concentrations will be assessed. Fat tissue probes will be used to characterise key enzymes and signalling pathways, redox status and whole genome expression. Modulation of the hormonal response to weight cycling is brought about by varying macronutrient content and glycemic index of the diets. We hypothesize that, insulin and leptin resistance are explained by increased insulin secretion during the refeeding period. Both, adaptive thermogenesis as well as insulin and leptin resistance can be ameliorated by attenuation of the increase in insulin and leptin secretion during refeeding a low GI diet after weight loss.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal weight (BMI 20-24 kg/m2), normal fat mass

Exclusion Criteria:

  • smoking, chronic diseases, drug intake, nutrient allergies, lactose intolerance, pacemaker, metalliferous implants
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737034


Locations
Germany
Institute of Human Nutrition
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Kiel
Investigators
Study Chair: Manfred J. Müller, Prof. Institute of Human Nutrition, University of Kiel
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Geisler C, Braun W, Pourhassan M, Schweitzer L, Glüer CC, Bosy-Westphal A, Müller MJ. Gender-Specific Associations in Age-Related Changes in Resting Energy Expenditure (REE) and MRI Measured Body Composition in Healthy Caucasians. J Gerontol A Biol Sci Med Sci. 2016 Jul;71(7):941-6. doi: 10.1093/gerona/glv211. Epub 2015 Nov 20.
Müller MJ, Enderle J, Pourhassan M, Braun W, Eggeling B, Lagerpusch M, Glüer CC, Kehayias JJ, Kiosz D, Bosy-Westphal A. Metabolic adaptation to caloric restriction and subsequent refeeding: the Minnesota Starvation Experiment revisited. Am J Clin Nutr. 2015 Oct;102(4):807-19. doi: 10.3945/ajcn.115.109173. Epub 2015 Sep 23.
Schweitzer L, Geisler C, Pourhassan M, Braun W, Glüer CC, Bosy-Westphal A, Müller MJ. What is the best reference site for a single MRI slice to assess whole-body skeletal muscle and adipose tissue volumes in healthy adults? Am J Clin Nutr. 2015 Jul;102(1):58-65. doi: 10.3945/ajcn.115.111203. Epub 2015 May 27.
Karschin J, Lagerpusch M, Enderle J, Eggeling B, Müller MJ, Bosy-Westphal A. Endocrine determinants of changes in insulin sensitivity and insulin secretion during a weight cycle in healthy men. PLoS One. 2015 Feb 27;10(2):e0117865. doi: 10.1371/journal.pone.0117865. eCollection 2015.
Lagerpusch M, Enderle J, Eggeling B, Braun W, Johannsen M, Pape D, Müller MJ, Bosy-Westphal A. Carbohydrate quality and quantity affect glucose and lipid metabolism during weight regain in healthy men. J Nutr. 2013 Oct;143(10):1593-601. doi: 10.3945/jn.113.179390. Epub 2013 Aug 14.

Responsible Party: Prof. Dr. Manfred James Müller, Principal Investigator, University of Kiel
ClinicalTrials.gov Identifier: NCT01737034     History of Changes
Other Study ID Numbers: BMBF 0315681
First Submitted: November 26, 2012
First Posted: November 29, 2012
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Prof. Dr. Manfred James Müller, University of Kiel:
partitioning of weight gain
refeeding
catch-up fat phenomenon
glycemic index


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