Clinical trial NCT01631123: NUtriGenomic Analysis in Twins
Official title: Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Response to Dietary Modification
Keywords: Twins
High carbohydrat diet
High fat diet
Isocaloric
Nutrigenomics
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Charite University, Berlin, Germany
name: Ernst von Bergmann Hospital
name: University Hospital Tuebingen
name: University of Southern California
name: Ludwig-Maximilians - University of Munich
name: Heidelberg University
name: HealthTwist GmbH, Berlin, Germany
name: Max-Planck Institute of Molecular Cell Biology and Genetics
name: Helmholtz Center Munich
First posted: 2012-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

Eligibility 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

Primary outcomes:
measure: Genetic variance of change in insulin secretion and sensitivity after sequential diets
timeFrame: 6,7,12 weeks
Secondary outcomes:
measure: Variance of insulin sensitivity after the sequential diets
timeFrame: 6, 7, 12 weeks
measure: Expression of inflammatory markers in blood and fat tissue
timeFrame: 6,7,12 weeks
measure: Development of indices for the prediction of fat mass
timeFrame: 6,7,12 weeks
measure: Changes in vessel wall thickness of the carotid artery
timeFrame: 6,7,12 weeks
measure: Measurement of activity
timeFrame: in the 6th, 7th, 12th week
measure: Detection of the gastric emptying time
timeFrame: 6,7,12 weeks
measure: Assessment of cognitive performance
timeFrame: 0,5,11 weeks
measure: Nutritional and genetic influence on the circadian rhythm
timeFrame: 6, 7, 12 weeks
measure: Epigenetic modification of DNA
timeFrame: 6,7,12 weeks
measure: Biometric data
timeFrame: 6,7,12 weeks
Other outcomes:
Locations:
city: Potsdam-Rehbruecke
country: Germany
facility: German Institute of Human Nutrition
state: Nuthetal
Study officials:
affiliation: German Institute of Human Nutrition Potsdam-Rehbruecke
name: Andreas FH Pfeiffer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuler R, Seebeck N, Osterhoff MA, Witte V, Floel A, Busjahn A, Jais A, Bruning JC, Frahnow T, Kabisch S, Pivovarova O, Hornemann S, Kruse M, Pfeiffer AFH. VEGF and GLUT1 are highly heritable, inversely correlated and affected by dietary fat intake: Consequences for cognitive function in humans. Mol Metab. 2018 May;11:129-136. doi: 10.1016/j.molmet.2018.02.004. Epub 2018 Feb 12.
citation: Schuler R, Osterhoff MA, Frahnow T, Seltmann AC, Busjahn A, Kabisch S, Xu L, Mosig AS, Spranger J, Mohlig M, Hornemann S, Kruse M, Pfeiffer AF. High-Saturated-Fat Diet Increases Circulating Angiotensin-Converting Enzyme, Which Is Enhanced by the rs4343 Polymorphism Defining Persons at Risk of Nutrient-Dependent Increases of Blood Pressure. J Am Heart Assoc. 2017 Jan 17;6(1):e004465. doi: 10.1161/JAHA.116.004465.
citation: Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.