Fructose-induced Hepatic De Novo Lipogenesis in South Asians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
研究概览
简要总结
The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in response to the ingestion of a mixture of glucose and fructose is greater in South Asians compared to controls (Caucasians).
详细描述
South Asians, who originate from the Indian subcontinent and make up one-fifth of the world's population, are among the highest number who suffer from heart disease and diabetes. The results of many research studies suggest that genes play a role in developing heart disease and diabetes that is made worse by the diet in the United States. Fructose is a sugar widely used in the American diet, and when consumed, it is taken up by the liver and changed into fats through a process called de novo lipogenesis (DNL). The current study will compare this change into fats in the liver between South Asians and Caucasians. The participants will be screened on the initial visit, and on the second visit, the DNL response will be measured in the blood over four hours after drinking one sweetened beverage, containing half glucose, half fructose, similar to a soft drink. We expect that DNL in response to fructose intake is higher in South Asians when compared to Caucasians and may partially explain why South Asians have earlier heart disease and diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18-35 years of age.
- •South Asian or Caucasian descent through self-identification (South Asians are to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh and no known non-South Asian ancestry in parents; Caucasians are to have both biological parents who self-identify as Caucasian and no known non-Caucasian ancestry in parents).
- •Body mass index (BMI) 18.0-24.9 kg/m2 with no history of obesity.
- •Fasting glucose <100 mg/dL, 2h glucose oral glucose tolerance test (OGTT) < 140 mg/dL.
- •triglycerides (TG) <200 mg/dL, HDL cholesterol (HDL-C) >30 mg/dL, LDL cholesterol (LDL-C) <160 mg/dL.
- •Willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to visit #2 until completion of study.
- •Willing to not drink alcohol for 24-hours before visit #
- •Willing and able to provide informed consent.
排除标准
- •History of diabetes or other endocrine disorder, hepatitis or other liver disorder, HIV, or autoimmune disease.
- •Medication(s) known to affect lipids, including hormonal contraceptives.
- •Recent acute illness
- •Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption.
- •Cigarette smoking
- •History of ethanol abuse (current intake >2 drinks/day) or illicit drugs.
- •History of severe psychiatric illness
- •If female, pregnant or breastfeeding
- •Participation in an investigational drug study within one month of screening.
- •Unusual diet or extreme level of physical activity
- •Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
研究组 & 干预措施
Caucasians
Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage.
干预措施: Fructose + Glucose Beverage (Other)
South Asians
Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage.
干预措施: Fructose + Glucose Beverage (Other)
结局指标
主要结局
Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
时间窗: 4 hours
Fold change in plasma very low density lipoprotein (VLDL) triglyceride palmitate between South Asians and Caucasians from baseline to 4 hours after an oral challenge of fructose:glucose, 1:1.
次要结局
- Peak Insulin Levels in 2 Study Groups(1 hour)
- Peak Lactate Levels in 2 Study Groups(1 hour)
- Peak Glucose Levels in 2 Study Groups(1 hour)
- Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups(2 hours)
- Peak Glucose in 2 Study Groups(1 hour)
- Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups(2 hours)
- Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism(4 hours)
- Fold Changes in VLDL Triglycerides in South Asians and Caucasians(4 hours)
- Fold Changes in Triglycerides in 2 Study Groups(4 hours)