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

• Sponsor: University of Kiel (Other)
• Overall Status: Completed
• CT.gov ID: NCT01737034
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 4
• Duration (Months): 19
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Dietary Intervention	Other: dietary intervention by varying GI diets	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Changes in body composition and energy metabolism after 3 weeks of underfeeding and 2 following weeks of refeeding [Body composition measurement after 4 and 6 study weeks]

   Body composition measurement including BODPOD, QMR, BIA Energy Metabolism measurement using indirect calorimetry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. Manfred James Müller, Principal Investigator, University of Kiel
• ClinicalTrials.gov Identifier: NCT01737034
• Other Study ID Numbers: BMBF 0315681
• First Posted: Nov 29, 2012
• Last Update Posted: Nov 30, 2012
• Last Verified: Nov 1, 2012

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

Study Results

No Results Posted as of Nov 30, 2012