Dietary InterventionNCT01737034
A Low Glycemic Index Diet as Prevention of the Catch-up Fat Phenomenon
A study testing dietary intervention by varying GI diets in people with Dietary Intervention, run by University of Kiel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Intervention
- What is being tested?
- dietary intervention by varying GI diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal weight (BMI 20-24 kg/m2), normal fat mass
Who cannot join
- smoking, chronic diseases, drug intake, nutrient allergies, lactose intolerance, pacemaker, metalliferous implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ätiologie, Pathophysiologie Und Prävention Einer überschießenden Körperfettzunahme Nach Gewichtsreduktion - Vermeidung Des JoJo-Effektes in Der Behandlung Von Übergewicht
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.
Read the 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.
- Conditions
- Dietary Intervention
- Being tested
- dietary intervention by varying GI diets
- Keywords
- partitioning of weight gain, refeeding, catch-up fat phenomenon, glycemic index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intervention by varying GI dietsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| low GI, low GI | Experimental | low GI diet (semi starvation phase) followed by low GI diet in the refeeding phase Receives: 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 Receives: 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 Receives: 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 Receives: Other: dietary intervention by varying GI diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Body composition measurement after 4 and 6 study weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dietary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Manfred James Müller, University of Kiel
- Investigators
- Manfred J. Müller, Prof., Study chair, Institute of Human Nutrition, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737034
- Sponsor's protocol ID
- BMBF 0315681
- Status last verified
- Nov 2012
- First submitted
- 26 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28060600Geisler 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.
PubMed 26590912Muller 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.
PubMed 26399868Schweitzer 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.
PubMed 26016860Karschin 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.
PubMed 25723719Lagerpusch 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.
PubMed 23946346
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ätiologie, Pathophysiologie Und Prävention Einer überschießenden Körperfettzunahme Nach Gewichtsreduktion - Vermeidung Des JoJo-Effektes in Der Behandlung Von Übergewicht
- ClinicalTrials.gov ID
- NCT01737034
- Acronym / sponsor ID
- BMBF 0315681
- Conditions
- Dietary Intervention
- Keywords
- partitioning of weight gain, refeeding, catch-up fat phenomenon, glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low GI, low GI | Experimental | Other: dietary intervention by varying GI dietslow GI diet (semi starvation phase) followed by low GI diet in the refeeding phase |
| low GI, high GI | Experimental | Other: dietary intervention by varying GI dietslow GI diet (semi starvation phase) followed by high GI diet in the refeeding phase |
| high GI, low GI | Experimental | Other: dietary intervention by varying GI dietshigh GI diet (semi starvation phase) followed by low GI diet in the refeeding phase |
| high GI, high GI | Experimental | Other: dietary intervention by varying GI dietshigh GI diet (semi starvation phase) followed by high GI diet in the refeeding phase |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- normal weight (BMI 20-24 kg/m2), normal fat mass
Key exclusion criteria (1 listed)
- smoking, chronic diseases, drug intake, nutrient allergies, lactose intolerance, pacemaker, metalliferous implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary intervention by varying GI dietsThe 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. | Other | high GI, high GI, high GI, low GI, low GI, high GI, low GI, low GI |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Derived from this study: PubMed 28060600Breusing 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.
- Derived from this study: PubMed 26590912Geisler 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.
- Derived from this study: PubMed 26399868Muller 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.
- Derived from this study: PubMed 26016860Schweitzer 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.
- Derived from this study: PubMed 25723719Karschin 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.
- Derived from this study: PubMed 23946346Lagerpusch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred J. Müller, Prof. study chair
Institute of Human Nutrition, University of Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention by varying GI diets in people with Dietary Intervention, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737034, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.