Metabolic Response to Dietary Modification
Conditions
Keywords
Twins, High carbohydrat diet, High fat diet, Isocaloric, Nutrigenomics
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.
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).
Interventions
OTHERIsocaloric high carbohydrate diet intervention
Time of 6 week, the last 6 days are standardized
OTHERIsocaloric high fat diet intervention
Time of 6 weeks; the first and the last 6 days are standardized
Sponsors
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 Center Munich
German Institute of Human Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genetic variance of change in insulin secretion and sensitivity after sequential diets | 6,7,12 weeks | change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression of inflammatory markers in blood and fat tissue | 6,7,12 weeks | Measurement of gene expression of inflammation cytokines and clock genes |
| Development of indices for the prediction of fat mass | 6,7,12 weeks | 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 | 6,7,12 weeks | Vascular ultrasound |
| Measurement of activity | in the 6th, 7th, 12th week | each over 6 days measurement: activity protocol, pedometer and activity clock |
| Variance of insulin sensitivity after the sequential diets | 6, 7, 12 weeks | change in insulin sensitivity measured with a meal tolerance test (MTT) allowing for the response of the intestinal hormones |
| Assessment of cognitive performance | 0,5,11 weeks | — |
| Nutritional and genetic influence on the circadian rhythm | 6, 7, 12 weeks | measurement of hormones in saliva and urine and of circadian gene expression in monocytes and PBMCs |
| Epigenetic modification of DNA | 6,7,12 weeks | Change in adipose tissue DNA methylation pattern |
| Biometric data | 6,7,12 weeks | Nutritional impact of the blood pressure, weight, body mass index, waist-hip ratio |
| Detection of the gastric emptying time | 6,7,12 weeks | — |
Countries
Germany
Outcome results
None listed