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

NCT ID: NCT01737034

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Intervention

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

partitioning of weight gain refeeding catch-up fat phenomenon glycemic index

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

low GI, low GI

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

Group Type EXPERIMENTAL

dietary intervention by varying GI diets

Intervention Type OTHER

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.

low GI, high GI

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

Group Type EXPERIMENTAL

dietary intervention by varying GI diets

Intervention Type OTHER

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, low GI

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

Group Type EXPERIMENTAL

dietary intervention by varying GI diets

Intervention Type OTHER

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 GI

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

Group Type EXPERIMENTAL

dietary intervention by varying GI diets

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Kiel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Manfred James Müller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manfred J. Müller, Prof.

Role: STUDY_CHAIR

Institute of Human Nutrition, University of Kiel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Human Nutrition

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28060600 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26590912 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26399868 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26016860 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25723719 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23946346 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMBF 0315681

Identifier Type: -

Identifier Source: org_study_id