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NUtriGenomic Analysis in Twins (NUGAT)

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ClinicalTrials.gov Identifier: NCT01631123
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : January 24, 2013
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
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 Center Munich
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Response to Dietary Modification Other: Isocaloric high carbohydrate diet intervention Other: Isocaloric high fat diet intervention Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies
Study Start Date : September 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : September 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Diet interventions
Sequential dietary intervention
 Other: Isocaloric high carbohydrate diet intervention
Time of 6 week, the last 6 days are standardized

Other: Isocaloric high fat diet intervention
Time of 6 weeks; the first and the last 6 days are standardized


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Variance of insulin sensitivity after the sequential diets [ Time Frame: 6, 7, 12 weeks ]
    change in insulin sensitivity measured with a meal tolerance test (MTT) allowing for the response of the intestinal hormones

  2. Expression of inflammatory markers in blood and fat tissue [ Time Frame: 6,7,12 weeks ]
    Measurement of gene expression of inflammation cytokines and clock genes

  3. Development of indices for the prediction of fat mass [ Time Frame: 6,7,12 weeks ]
    Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy, DEXA

  4. Changes in vessel wall thickness of the carotid artery [ Time Frame: 6,7,12 weeks ]
    Vascular ultrasound

  5. Measurement of activity [ Time Frame: in the 6th, 7th, 12th week ]
    each over 6 days measurement: activity protocol, pedometer and activity clock

  6. Detection of the gastric emptying time [ Time Frame: 6,7,12 weeks ]
  7. Assessment of cognitive performance [ Time Frame: 0,5,11 weeks ]
  8. Nutritional and genetic influence on the circadian rhythm [ Time Frame: 6, 7, 12 weeks ]
    measurement of hormones in saliva and urine and of circadian gene expression in monocytes and PBMCs

  9. Epigenetic modification of DNA [ Time Frame: 6,7,12 weeks ]
    Change in adipose tissue DNA methylation pattern

  10. Biometric data [ Time Frame: 6,7,12 weeks ]
    Nutritional impact of the blood pressure, weight, body mass index, waist-hip ratio


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631123


Locations
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Germany
German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, Germany, 14558
Sponsors and Collaborators
German Institute of Human Nutrition
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
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 Center Munich
Investigators
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Principal Investigator: Andreas FH Pfeiffer, Prof German Institute of Human Nutrition Potsdam-Rehbruecke
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Chief, Department of Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT01631123    
Other Study ID Numbers: BMBF NUGAT 0315424
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
Twins
High carbohydrat diet
High fat diet
Isocaloric
Nutrigenomics