This trial is active, not recruiting.

Conditions elevated triglycerides, diabetes, cardiovascular disease, dyslipidemia
Treatment fructose + glucose beverage
Sponsor The Rogosin Institute
Collaborator Weill Medical College of Cornell University
Start date March 2012
End date April 2017
Trial size 36 participants
Trial identifier NCT01562782, 1110011995


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
The arm is an oral sugar challenge with blood sampling over 4 hours.
fructose + glucose beverage
Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage.

Primary Outcomes

De novo lipogenesis
time frame: 4 hours

Secondary Outcomes

Biomarkers in South Asians and Caucasians
time frame: 4 hours

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

Inclusion Criteria: - 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 OGTT < 140 mg/dL. - TG <200 mg/dL, HDL cholesterol >30 mg/dL, LDL cholesterol <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 #2. - Willing and able to provide informed consent. Exclusion Criteria: - 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 GI 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

Additional Information

Official title Fructose-induced Hepatic De Novo Lipogenesis in South Asians
Principal investigator Lisa Hudgins, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The Rogosin Institute.