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Completed

NCT Number: NCT01631123

NUtriGenomic Analysis in Twins

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Institute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, 14558, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isocaloric high carbohydrate diet intervention

Other

Time of 6 week, the last 6 days are standardized

Isocaloric high fat diet intervention

Other

Time of 6 weeks; the first and the last 6 days are standardized

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Charite University, Berlin, Germany
  • Ernst von Bergmann Hospital
  • German Federal Ministry of Education and Research
  • HealthTwist GmbH, Berlin, Germany
  • Heidelberg University
  • Helmholtz Center Munich
  • Ludwig-Maximilians - University of Munich
  • Max-Planck Institute of Molecular Cell Biology and Genetics
  • University Hospital Tuebingen
  • University of Southern California

Registry information

Official study title

Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies

Acronym: NUGAT

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jun 28, 2012
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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