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

Dietary Intervention Clinical Trial

Official title:

Ätiologie, Pathophysiologie Und Prävention Einer überschießenden Körperfettzunahme Nach Gewichtsreduktion - Vermeidung Des JoJo-Effektes in Der Behandlung Von Übergewicht

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737034
• Other study ID #: BMBF 0315681
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: November 29, 2012
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dietary Intervention

Intervention

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.

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body composition and energy metabolism after 3 weeks of underfeeding and 2 following weeks of refeeding	Body composition measurement including BODPOD, QMR, BIA Energy Metabolism measurement using indirect calorimetry	Body composition measurement after 4 and 6 study weeks	No