The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 主要终点
- The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
研究概览
简要总结
The primary aim of this study is to investigate the acute changes in liver fat content in response to a fixed carbohydrate restriction (i.e. intake of 60g/day or 70g/day for women and men, respectively) in individuals with obesity. This will be performed both as 2 days of very low calorie diet (500 and 600 kcal/day for women and men, respectively) and 2 days of eucaloric low carbohydrate diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men (30-75 years) and postmenopausal women 45-75 years old
- •Hba1c <48 mmol/mol without antidiabetic treatment
- •Obese (BMI 27-40 kg/m2)
- •Non smokers
排除标准
- •Anemia (hemoglobin <8 mmol/L for men and <7 mmol/L for women)
- •TSH outside reference range
- •Medication known to influence glucose metabolism or appetite regulation
- •Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
- •Food allergies (including lactose and gluten intolerance), vegetarian/vegan diet or following specific dietary plans
- •Alcohol consumptions >84/168 g/week (women/men)
- •Strenuous activity level > 120 minutes per week
- •>5 kg weight loss within the last three months or previous bariatric surgery
- •High risk of fibrosis of the liver (estimated by FIB4 score > 3,25)
结局指标
主要结局
The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
时间窗: After 2 days completion of dietary intervention
We will compare MRS of liver TG after each of the two interventions (2 days of VLCD or 2 days of LC) with MRS liver TG obtained after 2 days of eucaloric conventional diet.
次要结局
- Secondary outcomes are fasting and postprandial plasma glucose, insulin, and plasma TG concentrations after 2 days VLCD or LC compared with 2 days of eucaloric conventional diet.(After 2 days completion of dietary intervention)
研究者
Kirstine Nyvold Bojsen-Moeller
Principal investigator, MD, PhD Affiliation: Hvidovre University Hospital
Hvidovre University Hospital