Change of Fructose to Fat in South Asians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562782
Recruitment Status : Active, not recruiting
First Posted : March 26, 2012
Last Update Posted : July 21, 2016
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Elevated Triglycerides Diabetes Cardiovascular Disease Dyslipidemia Other: Fructose + Glucose Beverage Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fructose-induced Hepatic De Novo Lipogenesis in South Asians
Study Start Date : March 2012
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fructose + Glucose Beverage
The arm is an oral sugar challenge with blood sampling over 4 hours.
Other: 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 Outcome Measures :
  1. De novo lipogenesis [ Time Frame: 4 hours ]
    Difference from baseline in plasma VLDL TG %palmitate between South Asians and Caucasians 4 hours after an oral challenge of fructose:glucose, 1:1

Secondary Outcome Measures :
  1. Biomarkers in South Asians and Caucasians [ Time Frame: 4 hours ]
    1. To compare markers of carbohydrate and fatty acid metabolism, i.e. VLDL and total TG, cholesterol, apolipoprotein B, free fatty acids, insulin, glucose, fructose, lactate and glucose-dependent insulinotropic polypeptide (GIP, a marker of gastric emptying).
    2. To correlate these markers with the increase in VLDL TG palmitate.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562782

United States, New York
The Rogosin Institute
New York, New York, United States, 10065
Weill Cornell Medical College Clinical and Translational Science Center (CTSC)
New York, New York, United States, 10065
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Principal Investigator: Lisa Hudgins, MD The Rogosin Institute

Responsible Party: The Rogosin Institute Identifier: NCT01562782     History of Changes
Other Study ID Numbers: 1110011995
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Keywords provided by The Rogosin Institute:
Elevated triglycerides
Diabetes Mellitus
Lipid Metabolic Disorders
Body Weight

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases