NCT01737034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

November 26, 2012

Last Update Submit

November 29, 2012

Conditions

Keywords

partitioning of weight gainrefeedingcatch-up fat phenomenonglycemic index

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

low GI, low GI

EXPERIMENTAL

low GI diet (semi starvation phase) followed by low GI diet in the refeeding phase

Other: dietary intervention by varying GI diets

low GI, high GI

EXPERIMENTAL

low GI diet (semi starvation phase) followed by high GI diet in the refeeding phase

Other: dietary intervention by varying GI diets

high GI, low GI

EXPERIMENTAL

high GI diet (semi starvation phase) followed by low GI diet in the refeeding phase

Other: dietary intervention by varying GI diets

high GI, high GI

EXPERIMENTAL

high GI diet (semi starvation phase) followed by high GI diet in the refeeding phase

Other: dietary intervention by varying GI diets

Interventions

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.

high GI, high GIhigh GI, low GIlow GI, high GIlow GI, low GI

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • smoking, chronic diseases, drug intake, nutrient allergies, lactose intolerance, pacemaker, metalliferous implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (6)

  • Breusing N, Lagerpusch M, Engstler AJ, Bergheim I, Mueller MJ, Bosy-Westphal A. Influence of Energy Balance and Glycemic Index on Metabolic Endotoxemia in Healthy Men. J Am Coll Nutr. 2017 Jan;36(1):72-79. doi: 10.1080/07315724.2016.1156036. Epub 2017 Jan 6.

  • Geisler C, Braun W, Pourhassan M, Schweitzer L, Gluer CC, Bosy-Westphal A, Muller 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.

  • Muller MJ, Enderle J, Pourhassan M, Braun W, Eggeling B, Lagerpusch M, Gluer 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, Gluer CC, Bosy-Westphal A, Muller 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, Muller 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, Muller 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.

Study Officials

  • Manfred J. Müller, Prof.

    Institute of Human Nutrition, University of Kiel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 29, 2012

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations