Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Genetic variance of change in insulin secretion and sensitivity after sequential diets
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
- Variance of insulin sensitivity after the sequential diets(6, 7, 12 weeks)
- Development of indices for the prediction of fat mass(6,7,12 weeks)
- Changes in vessel wall thickness of the carotid artery(6,7,12 weeks)
- Biometric data(6,7,12 weeks)
- Nutritional and genetic influence on the circadian rhythm(6, 7, 12 weeks)
- Expression of inflammatory markers in blood and fat tissue(6,7,12 weeks)
- Measurement of activity(in the 6th, 7th, 12th week)
- Epigenetic modification of DNA(6,7,12 weeks)
- Detection of the gastric emptying time(6,7,12 weeks)
- Assessment of cognitive performance(0,5,11 weeks)
Investigators
Prof. Dr. med. Andreas F. H. Pfeiffer
Chief, Department of Clinical Nutrition
German Institute of Human Nutrition