Change of Fructose to Fat in South Asians

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The Rogosin Institute
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01562782
First received: March 22, 2012
Last updated: May 22, 2014
Last verified: May 2014

March 22, 2012
May 22, 2014
March 2012
April 2015   (final data collection date for primary outcome measure)
De novo lipogenesis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Difference from baseline in plasma VLDL TG %palmitate between South Asians and Caucasians 4 hours after an oral challenge of fructose:glucose, 1:1
Same as current
Complete list of historical versions of study NCT01562782 on ClinicalTrials.gov Archive Site
Biomarkers in South Asians and Caucasians [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  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.
Same as current
Not Provided
Not Provided
 
Change of Fructose to Fat in South Asians
Fructose-induced Hepatic De Novo Lipogenesis in South Asians

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).

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Elevated Triglycerides
  • Diabetes
  • Cardiovascular Disease
  • Dyslipidemia
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.
Experimental: Fructose + Glucose Beverage
The arm is an oral sugar challenge with blood sampling over 4 hours.
Intervention: Other: Fructose + Glucose Beverage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact: Nancy Olowo 646-962-8313 nao2012@med.cornell.edu
Contact: Lisa Hudgins, MD 646-317-0805 lih2013@nyp.org
United States
 
NCT01562782
1110011995
No
The Rogosin Institute
The Rogosin Institute
Weill Medical College of Cornell University
Principal Investigator: Lisa Hudgins, MD The Rogosin Institute
The Rogosin Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP