NUtriGenomic Analysis in Twins

German Institute of Human Nutrition120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

120

Conditions

Metabolic Response to Dietary Modification

Interventions

Isocaloric high carbohydrate diet interventionOTHER

Time of 6 week, the last 6 days are standardized

Isocaloric high fat diet interventionOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

German Institute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, Germany

Outcomes

Primary Outcomes

Genetic variance of change in insulin secretion and sensitivity after sequential diets

change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT)

Time frame: 6,7,12 weeks

Secondary Outcomes

Variance of insulin sensitivity after the sequential diets

change in insulin sensitivity measured with a meal tolerance test (MTT) allowing for the response of the intestinal hormones

Time frame: 6, 7, 12 weeks

Expression of inflammatory markers in blood and fat tissue

Measurement of gene expression of inflammation cytokines and clock genes

Time frame: 6,7,12 weeks

Development of indices for the prediction of fat mass

Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy, DEXA

Time frame: 6,7,12 weeks

Changes in vessel wall thickness of the carotid artery

Vascular ultrasound

Time frame: 6,7,12 weeks

Measurement of activity

each over 6 days measurement: activity protocol, pedometer and activity clock

Time frame: in the 6th, 7th, 12th week

Detection of the gastric emptying time

Time frame: 6,7,12 weeks

Assessment of cognitive performance

Time frame: 0,5,11 weeks

Data from ClinicalTrials.gov

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