Metabolic Response to Dietary ModificationNUGATNCT01631123
NUtriGenomic Analysis in Twins
A study testing Isocaloric high carbohydrate diet intervention and Isocaloric high fat diet intervention in people with Metabolic Response to Dietary Modification, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
This is an intervention study in healthy adult twins with the aim to investigate the genetic determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Response to Dietary Modification
- What is being tested?
- Isocaloric high carbohydrate diet intervention and Isocaloric high fat diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Sep 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy twins
- BMI 18,5-35kg/m²
- BMI difference < 3kg/m² within the pair of twins
- Stable weight during the last 3 months
- Willingness to comply with the assigned diets over the study period
Who cannot join
- Consumptive diseases
- Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
- Diabetes type 1 and type 2
- Pregnancy
- Chronic disease of heart, kidney, liver
- High grade anaemia
Show all 11Show fewer
- High grade infection disease
- Relevant change of body weight(+/- 2kg)during isoenergetic 12-weeks of dietary intervention
- Missing data about primary outcome measures (IVGTT, MTT, data about dietary intake from food diaries or food protocols)
- Significant deviation from dietary targets during the monitored 12 weeks isoenergetic period
- Allergies including food allergies
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, 14558
About this study
Official title: Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies
This is an intervention study in healthy adult twins with the aim to investigate the genetic determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet.
Read the detailed description
The impact of carbohydrates, proteins and fatty acids as major components of daily nutrition on the development of metabolic illnesses is an objective of numerous clinical studies. However, the effect of an isocaloric diet on metabolism is less investigated and not well understood. This study aims to reveal genetic determinated metabolic responses to an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet in healthy twins. This study generates information for further detailed nutrigenomic analysis. Twins receive an isocaloric diet rich in carbohydrates (55% carbohydrates, 15% protein, 30% fat) with dietary counselling for 5 weeks and afterwards with nutrients supplied for 6 days, followed by an isocaloric diet rich in saturated fat (40% carbohydrates, 15% protein, 45% fat) for 6 days with nutrients supplied and for 4 weeks with dietary counselling and again followed by another 6 days when nutrients were supplied. Anthropometry, blood tests and energy expenditure are performed after the period of diet rich in carbohydrates (Carb), after the first 6 days (HFshort) and at the end of the period of diet rich in fat (HFlong).
- Being tested
- Isocaloric high carbohydrate diet intervention, Isocaloric high fat diet intervention
- Keywords
- Twins, High carbohydrat diet, High fat diet, Isocaloric, Nutrigenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isocaloric high carbohydrate diet interventionOther
Time of 6 week, the last 6 days are standardized
Isocaloric high fat diet interventionOther
Time of 6 weeks; the first and the last 6 days are standardized
| Study group | Role | What they receive |
|---|---|---|
| Diet interventions | Experimental | Sequential dietary intervention Receives: Other: Isocaloric high carbohydrate diet intervention; Other: Isocaloric high fat diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variance of change in insulin secretion and sensitivity after sequential diets
change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT)
Measured: 6,7,12 weeks
Secondary outcomes (10)
Variance of insulin sensitivity after the sequential diets
change in insulin sensitivity measured with a meal tolerance test (MTT) allowing for the response of the intestinal hormones
Measured: 6, 7, 12 weeks
Expression of inflammatory markers in blood and fat tissue
Measurement of gene expression of inflammation cytokines and clock genes
Measured: 6,7,12 weeks
Development of indices for the prediction of fat mass
Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy, DEXA
Measured: 6,7,12 weeks
Changes in vessel wall thickness of the carotid artery
Vascular ultrasound
Measured: 6,7,12 weeks
Measurement of activity
each over 6 days measurement: activity protocol, pedometer and activity clock
Measured: in the 6th, 7th, 12th week
Detection of the gastric emptying time
Measured: 6,7,12 weeks
Assessment of cognitive performance
Measured: 0,5,11 weeks
Nutritional and genetic influence on the circadian rhythm
measurement of hormones in saliva and urine and of circadian gene expression in monocytes and PBMCs
Measured: 6, 7, 12 weeks
Epigenetic modification of DNA
Change in adipose tissue DNA methylation pattern
Measured: 6,7,12 weeks
Biometric data
Nutritional impact of the blood pressure, weight, body mass index, waist-hip ratio
Measured: 6,7,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic Response to Dietary ModificationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Charite University, Berlin, Germany, Ernst von Bergmann Hospital, University Hospital Tuebingen, University of Southern California, Ludwig-Maximilians - University of Munich, Heidelberg University, HealthTwist GmbH, Berlin, Germany, Max-Planck Institute of Molecular Cell Biology and Genetics, Helmholtz Zentrum München
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
- Investigators
- Andreas FH Pfeiffer, Prof, Principal investigator, German Institute of Human Nutrition Potsdam-Rehbruecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631123
- Sponsor's protocol ID
- BMBF NUGAT 0315424
- Acronym
- NUGAT
- Status last verified
- Jan 2013
- First submitted
- 1 Jun 2012
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schuler R, Seebeck N, Osterhoff MA, Witte V, Floel A, Busjahn A, Jais A, Bruning JC, Frahnow T, Kabisch S, Pivovarova O, Hornemann S, Kruse M, Pfeiffer AFH. VEGF and GLUT1 are highly heritable, inversely correlated and affected by dietary fat intake: Consequences for cognitive function in humans. Mol Metab. 2018 May;11:129-136. doi: 10.1016/j.molmet.2018.02.004. Epub 2018 Feb 12.
PubMed 29506909Schuler R, Osterhoff MA, Frahnow T, Seltmann AC, Busjahn A, Kabisch S, Xu L, Mosig AS, Spranger J, Mohlig M, Hornemann S, Kruse M, Pfeiffer AF. High-Saturated-Fat Diet Increases Circulating Angiotensin-Converting Enzyme, Which Is Enhanced by the rs4343 Polymorphism Defining Persons at Risk of Nutrient-Dependent Increases of Blood Pressure. J Am Heart Assoc. 2017 Jan 17;6(1):e004465. doi: 10.1161/JAHA.116.004465.
PubMed 28096099Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.
PubMed 25822100
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies
- ClinicalTrials.gov ID
- NCT01631123
- Acronym / sponsor ID
- NUGAT / BMBF NUGAT 0315424
- Keywords
- Twins, High carbohydrat diet, High fat diet, Isocaloric, Nutrigenomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Charite University, Berlin, Germany, Ernst von Bergmann Hospital, University Hospital Tuebingen, University of Southern California, Ludwig-Maximilians - University of Munich, Heidelberg University, HealthTwist GmbH, Berlin, Germany, Max-Planck Institute of Molecular Cell Biology and Genetics, Helmholtz Zentrum München
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Jun 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.
This is an intervention study in healthy adult twins with the aim to investigate the genetic determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet.
Detailed description
The impact of carbohydrates, proteins and fatty acids as major components of daily nutrition on the development of metabolic illnesses is an objective of numerous clinical studies. However, the effect of an isocaloric diet on metabolism is less investigated and not well understood. This study aims to reveal genetic determinated metabolic responses to an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet in healthy twins. This study generates information for further detailed nutrigenomic analysis. Twins receive an isocaloric diet rich in carbohydrates (55% carbohydrates, 15% protein, 30% fat) with dietary counselling for 5 weeks and afterwards with nutrients supplied for 6 days, followed by an isocaloric diet rich in saturated fat (40% carbohydrates, 15% protein, 45% fat) for 6 days with nutrients supplied and for 4 weeks with dietary counselling and again followed by another 6 days when nutrients were supplied. Anthropometry, blood tests and energy expenditure are performed after the period of diet rich in carbohydrates (Carb), after the first 6 days (HFshort) and at the end of the period of diet rich in fat (HFlong).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet interventions | Experimental | Other: Isocaloric high carbohydrate diet intervention, Other: Isocaloric high fat diet interventionSequential dietary intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy twins
- BMI 18,5-35kg/m²
- BMI difference < 3kg/m² within the pair of twins
- Stable weight during the last 3 months
- Willingness to comply with the assigned diets over the study period
Key exclusion criteria (11 listed)
- Consumptive diseases
- Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
- Diabetes type 1 and type 2
- Pregnancy
- Chronic disease of heart, kidney, liver
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 |
|---|---|---|
| Isocaloric high carbohydrate diet interventionTime of 6 week, the last 6 days are standardized | Other | Diet interventions |
| Isocaloric high fat diet interventionTime of 6 weeks; the first and the last 6 days are standardized | Other | Diet interventions |
Primary outcome
Genetic variance of change in insulin secretion and sensitivity after sequential diets
Time frame: 6,7,12 weeks
change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT)
10 secondary outcomes
Variance of insulin sensitivity after the sequential diets
Time frame: 6, 7, 12 weeks
Expression of inflammatory markers in blood and fat tissue
Time frame: 6,7,12 weeks
Development of indices for the prediction of fat mass
Time frame: 6,7,12 weeks
Changes in vessel wall thickness of the carotid artery
Time frame: 6,7,12 weeks
Measurement of activity
Time frame: in the 6th, 7th, 12th week
Detection of the gastric emptying time
Time frame: 6,7,12 weeks
Assessment of cognitive performance
Time frame: 0,5,11 weeks
Nutritional and genetic influence on the circadian rhythm
Time frame: 6, 7, 12 weeks
Epigenetic modification of DNA
Time frame: 6,7,12 weeks
Biometric data
Time frame: 6,7,12 weeks
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 24 Jan 2013.
- Derived from this study: PubMed 29506909Schuler R, Seebeck N, Osterhoff MA, Witte V, Floel A, Busjahn A, Jais A, Bruning JC, Frahnow T, Kabisch S, Pivovarova O, Hornemann S, Kruse M, Pfeiffer AFH. VEGF and GLUT1 are highly heritable, inversely correlated and affected by dietary fat intake: Consequences for cognitive function in humans. Mol Metab. 2018 May;11:129-136. doi: 10.1016/j.molmet.2018.02.004. Epub 2018 Feb 12.
- Derived from this study: PubMed 28096099Schuler R, Osterhoff MA, Frahnow T, Seltmann AC, Busjahn A, Kabisch S, Xu L, Mosig AS, Spranger J, Mohlig M, Hornemann S, Kruse M, Pfeiffer AF. High-Saturated-Fat Diet Increases Circulating Angiotensin-Converting Enzyme, Which Is Enhanced by the rs4343 Polymorphism Defining Persons at Risk of Nutrient-Dependent Increases of Blood Pressure. J Am Heart Assoc. 2017 Jan 17;6(1):e004465. doi: 10.1161/JAHA.116.004465.
- Derived from this study: PubMed 25822100Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.
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.
Andreas FH Pfeiffer, Prof principal investigator
German Institute of Human Nutrition Potsdam-Rehbruecke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isocaloric high carbohydrate diet intervention and Isocaloric high fat diet intervention in people with Metabolic Response to Dietary Modification, run by German Institute of Human Nutrition 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 5 inclusion and 11 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 24 Jan 2013. 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?
Genetic variance of change in insulin secretion and sensitivity after sequential diets (time frame: 6,7,12 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 NCT01631123, which also lists 3 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 24 Jan 2013; AzTrials last refreshed its copy on 28 Oct 2026.