NUtriGenomic Analysis in Twins (NUGAT)

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Clinical Ernst von Bergmann, Potsdam
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, Dresden
Helmholtz Center Munich
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
ClinicalTrials.gov Identifier:
NCT01631123
First received: June 1, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention
Metabolic Response to Dietary Modification
Other: Isocaloric high carbohydrate diet intervention
Other: Isocaloric high fat diet intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies

Resource links provided by NLM:


Further study details as provided by German Institute of Human Nutrition:

Primary Outcome Measures:
  • Genetic variance of change in insulin secretion and sensitivity after sequential diets [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
    change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT)


Secondary Outcome Measures:
  • Variance of insulin sensitivity after the sequential diets [ Time Frame: 6, 7, 12 weeks ] [ Designated as safety issue: No ]
    change in insulin sensitivity measured with a meal tolerance test (MTT) allowing for the response of the intestinal hormones

  • Expression of inflammatory markers in blood and fat tissue [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
    Measurement of gene expression of inflammation cytokines and clock genes

  • Development of indices for the prediction of fat mass [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
    Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy, DEXA

  • Changes in vessel wall thickness of the carotid artery [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
    Vascular ultrasound

  • Measurement of activity [ Time Frame: in the 6th, 7th, 12th week ] [ Designated as safety issue: No ]
    each over 6 days measurement: activity protocol, pedometer and activity clock

  • Detection of the gastric emptying time [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
  • Assessment of cognitive performance [ Time Frame: 0,5,11 weeks ] [ Designated as safety issue: No ]
  • Nutritional and genetic influence on the circadian rhythm [ Time Frame: 6, 7, 12 weeks ] [ Designated as safety issue: No ]
    measurement of hormones in saliva and urine and of circadian gene expression in monocytes and PBMCs

  • Epigenetic modification of DNA [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
    Change in adipose tissue DNA methylation pattern

  • Biometric data [ Time Frame: 6,7,12 weeks ] [ Designated as safety issue: No ]
    Nutritional impact of the blood pressure, weight, body mass index, waist-hip ratio


Enrollment: 120
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631123

Locations
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
Clinical Ernst von Bergmann, Potsdam
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, Dresden
Helmholtz Center Munich
Investigators
Principal Investigator: Andreas FH Pfeiffer, Prof German Institute of Human Nutrition Potsdam-Rehbruecke
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Chief, Department of Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT01631123     History of Changes
Other Study ID Numbers: BMBF NUGAT 0315424
Study First Received: June 1, 2012
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by German Institute of Human Nutrition:
Twins
High carbohydrat diet
High fat diet
Isocaloric
Nutrigenomics

ClinicalTrials.gov processed this record on September 16, 2014