Change of Fructose to Fat in South Asians

NCT01562782 | Completed Results

• 1 other identifier: 1110011995
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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).

Conditions

Elevated Triglycerides; Diabetes; Cardiovascular Disease; Dyslipidemia

Keywords

Elevated triglycerides; Diabetes Mellitus; Dyslipidemia; Lipid Metabolic Disorders; Body Weight

Outcome Measures

Primary Outcomes (1)

• Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate

  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.

  4 hours

Secondary Outcomes (9)

• Fold Changes in VLDL Triglycerides in South Asians and Caucasians

  4 hours

• Peak Glucose Levels in 2 Study Groups

  1 hour

• Peak Insulin Levels 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

Study Arms (2)

South Asians

EXPERIMENTAL

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

Other: Fructose + Glucose Beverage

Caucasians

ACTIVE COMPARATOR

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

Other: Fructose + Glucose Beverage

Interventions

Fructose + Glucose Beverage 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; South Asians

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Rogosin Institute: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

The Rogosin Institute

New York, New York, 10065, United States

Location

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

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Diabetes Mellitus; Cardiovascular Diseases; Dyslipidemias; Body Weight

Interventions

Fructose

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Lisa Hudgins, M.D.
• Organization: The Rogosin Institute

lih2013@nyp.org

646-317-0805

Study Officials

• Lisa Hudgins, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: April 2, 2012
• Primary Completion: October 10, 2013
• Study Completion: October 10, 2013
• Last Updated: March 12, 2024
• Results First Posted: July 19, 2019

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)