Genetic Determinants of Metabolic Responses to Isocaloric Carbohydrate and Fat Diet Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Genetic variance of change in insulin secretion and sensitivity after sequential diets
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diet interventions
Sequential dietary intervention
干预措施: Isocaloric high carbohydrate diet intervention (Other)
Diet interventions
Sequential dietary intervention
干预措施: Isocaloric high fat diet intervention (Other)
结局指标
主要结局
Genetic variance of change in insulin secretion and sensitivity after sequential diets
时间窗: 6,7,12 weeks
change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT)
次要结局
- Detection of the gastric emptying time(6,7,12 weeks)
- Assessment of cognitive performance(0,5,11 weeks)
- Expression of inflammatory markers in blood and fat tissue(6,7,12 weeks)
- Variance of insulin sensitivity after the sequential diets(6, 7, 12 weeks)
- Development of indices for the prediction of fat mass(6,7,12 weeks)
- Changes in vessel wall thickness of the carotid artery(6,7,12 weeks)
- Biometric data(6,7,12 weeks)
- Nutritional and genetic influence on the circadian rhythm(6, 7, 12 weeks)
- Measurement of activity(in the 6th, 7th, 12th week)
- Epigenetic modification of DNA(6,7,12 weeks)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Chief, Department of Clinical Nutrition
German Institute of Human Nutrition