Change of Fructose to Fat in South Asians

NCT ID: NCT01562782

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-02
• Study Completion Date: 2013-10-10

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).

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.

Conditions

Elevated Triglycerides; Diabetes; Cardiovascular Disease; Dyslipidemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

South Asians

Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage.

Group Type: EXPERIMENTAL

Fructose + Glucose Beverage

Intervention Type: OTHER

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.

Caucasians

Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage.

Group Type: ACTIVE_COMPARATOR

Fructose + Glucose Beverage

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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 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 #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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

The Rogosin Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Hudgins, MD

Role: PRINCIPAL_INVESTIGATOR

The Rogosin Institute

Locations

The Rogosin Institute

New York, New York, United States

Weill Cornell Medical College Clinical and Translational Science Center (CTSC)

New York, New York, United States

Countries

United States

Other Identifiers

1110011995

Identifier Type: -

Identifier Source: org_study_id