NUtriGenomic Analysis in Twins (NUGAT)

German Institute of Human Nutrition

Status: Completed

Conditions: Metabolic Response to Dietary Modification

Treatments: Other: Isocaloric high carbohydrate diet intervention; Other: Isocaloric high fat diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01631123

BMBF NUGAT 0315424

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Diet interventions

Experimental group

Description:

Sequential dietary intervention

Treatment:

Other: Isocaloric high fat diet intervention

Other: Isocaloric high carbohydrate diet intervention