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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.
 
ClinicalTrials.gov Identifier: NCT01562782
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Fructose-induced Hepatic De Novo Lipogenesis in South Asians
Actual Study Start Date : April 2, 2012
Actual Primary Completion Date : October 10, 2013
Actual Study Completion Date : October 10, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arm Intervention/treatment
Experimental: South Asians
Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage.
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.

Active Comparator: Caucasians
Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage.
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. Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate [ Time Frame: 4 hours ]
    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.


Secondary Outcome Measures :
  1. Fold Changes in VLDL Triglycerides in South Asians and Caucasians [ Time Frame: 4 hours ]
    1) A comparison of the fold changes in very low density lipoprotein triglycerides (VLDL TG)in the 2 study groups between 0 and 4 hours.

  2. Peak Glucose Levels in 2 Study Groups [ Time Frame: 1 hour ]
    A comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose.

  3. Peak Insulin Levels in 2 Study Groups [ Time Frame: 1 hour ]
    A comparison of the mean peak insulin level at one hour in each group. Insulin is expected to increase after ingestion of glucose/fructose.

  4. Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups [ Time Frame: 2 hours ]
    A comparison of the mean peak gastric inhibitory protein (GIP) at 2 hours in each group. GIP is expected to increase after ingestion of glucose/fructose.

  5. Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism [ Time Frame: 4 hours ]
    Correlations between fold change in VLDL TG palmitate at 4 hours with other biomarkers of carbohydrate and fat metabolism in each study group.

  6. Fold Changes in Triglycerides in 2 Study Groups [ Time Frame: 4 hours ]
    1) A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.

  7. Peak Lactate Levels in 2 Study Groups [ Time Frame: 1 hour ]
    A comparison of peak levels of lactate (at one hour). Lactate is expected to increase after ingestion of glucose/fructose.

  8. Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups [ Time Frame: 2 hours ]
    A comparison of the nadir level of non-esterified fatty acids (NEFA at 2 hours). NEFA are expected to decrease.

  9. Peak Glucose in 2 Study Groups [ Time Frame: 1 hour ]
    A comparison of peak levels of glucose at 1 hour. Glucose is expected to increase after ingestion of glucose/fructose.



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT01562782


Locations
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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
Investigators
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Principal Investigator: Lisa Hudgins, MD The Rogosin Institute
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Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01562782    
Other Study ID Numbers: 1110011995
First Posted: March 26, 2012    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Rogosin Institute:
Elevated triglycerides
Diabetes Mellitus
Dyslipidemia
Lipid Metabolic Disorders
Body Weight
Additional relevant MeSH terms:
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Cardiovascular Diseases
Dyslipidemias
Hypertriglyceridemia
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias