NUtriGenomic Analysis in Twins (NUGAT)
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ClinicalTrials.gov Identifier: NCT01631123 |
Recruitment Status :
Completed
First Posted : June 28, 2012
Last Update Posted : January 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Response to Dietary Modification | Other: Isocaloric high carbohydrate diet intervention Other: Isocaloric high fat diet intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | September 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Diet interventions
Sequential dietary intervention
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Other: Isocaloric high carbohydrate diet intervention
Time of 6 week, the last 6 days are standardized Other: Isocaloric high fat diet intervention Time of 6 weeks; the first and the last 6 days are standardized |
- 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)
- Variance of insulin sensitivity after the sequential diets [ Time Frame: 6, 7, 12 weeks ]change in insulin sensitivity measured with a meal tolerance test (MTT) allowing for the response of the intestinal hormones
- Expression of inflammatory markers in blood and fat tissue [ Time Frame: 6,7,12 weeks ]Measurement of gene expression of inflammation cytokines and clock genes
- Development of indices for the prediction of fat mass [ Time Frame: 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 [ Time Frame: 6,7,12 weeks ]Vascular ultrasound
- Measurement of activity [ Time Frame: in the 6th, 7th, 12th week ]each over 6 days measurement: activity protocol, pedometer and activity clock
- Detection of the gastric emptying time [ Time Frame: 6,7,12 weeks ]
- Assessment of cognitive performance [ Time Frame: 0,5,11 weeks ]
- Nutritional and genetic influence on the circadian rhythm [ Time Frame: 6, 7, 12 weeks ]measurement of hormones in saliva and urine and of circadian gene expression in monocytes and PBMCs
- Epigenetic modification of DNA [ Time Frame: 6,7,12 weeks ]Change in adipose tissue DNA methylation pattern
- Biometric data [ Time Frame: 6,7,12 weeks ]Nutritional impact of the blood pressure, weight, body mass index, waist-hip ratio

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631123
Germany | |
German Institute of Human Nutrition | |
Potsdam-Rehbruecke, Nuthetal, Germany, 14558 |
Principal Investigator: | Andreas FH Pfeiffer, Prof | German Institute of Human Nutrition Potsdam-Rehbruecke |
Responsible Party: | Prof. Dr. med. Andreas F. H. Pfeiffer, Chief, Department of Clinical Nutrition, German Institute of Human Nutrition |
ClinicalTrials.gov Identifier: | NCT01631123 |
Other Study ID Numbers: |
BMBF NUGAT 0315424 |
First Posted: | June 28, 2012 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Twins High carbohydrat diet High fat diet Isocaloric Nutrigenomics |