NUtriGenomic Analysis in Twins

Not Applicable

Completed

• Conditions: Metabolic Response to Dietary Modification
• Interventions: Other: Isocaloric high carbohydrate diet intervention; Other: Isocaloric high fat diet intervention

• Registration Number: NCT01631123
• Lead Sponsor: German Institute of Human Nutrition

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2010-01
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet interventions	Isocaloric high fat diet intervention	Sequential dietary intervention
Diet interventions	Isocaloric high carbohydrate diet intervention	Sequential dietary intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Biometric data	6,7,12 weeks	Nutritional impact of the blood pressure, weight, body mass index, waist-hip ratio
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
Expression of inflammatory markers in blood and fat tissue	6,7,12 weeks	Measurement of gene expression of inflammation cytokines and clock genes
Measurement of activity	in the 6th, 7th, 12th week	each over 6 days measurement: activity protocol, pedometer and activity clock
Epigenetic modification of DNA	6,7,12 weeks	Change in adipose tissue DNA methylation pattern
Detection of the gastric emptying time	6,7,12 weeks
Assessment of cognitive performance	0,5,11 weeks

Trial Locations

Locations (1)

German Institute of Human Nutrition; 🇩🇪 Potsdam-Rehbruecke, Nuthetal, Germany