Back to resultsChange of Fructose to Fat in South Asians
Primary Purpose
Elevated Triglycerides, Diabetes, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fructose + Glucose Beverage
Sponsored by
About this trial
This is an interventional screening trial for Elevated Triglycerides focused on measuring Elevated triglycerides, Diabetes Mellitus, Dyslipidemia, Lipid Metabolic Disorders, Body Weight
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
Sites / Locations
- The Rogosin Institute
- Weill Cornell Medical College Clinical and Translational Science Center (CTSC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
South Asians
Caucasians
Arm Description
Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage.
Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Fold Changes in VLDL Triglycerides in South Asians and Caucasians
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.
Peak Glucose Levels in 2 Study Groups
A comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose.
Peak Insulin Levels in 2 Study Groups
A comparison of the mean peak insulin level at one hour in each group. Insulin is expected to increase after ingestion of glucose/fructose.
Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups
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.
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
Correlations between fold change in VLDL TG palmitate at 4 hours with other biomarkers of carbohydrate and fat metabolism in each study group.
Fold Changes in Triglycerides in 2 Study Groups
1) A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.
Peak Lactate Levels in 2 Study Groups
A comparison of peak levels of lactate (at one hour). Lactate is expected to increase after ingestion of glucose/fructose.
Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups
A comparison of the nadir level of non-esterified fatty acids (NEFA at 2 hours). NEFA are expected to decrease.
Peak Glucose in 2 Study Groups
A comparison of peak levels of glucose at 1 hour. Glucose is expected to increase after ingestion of glucose/fructose.
Full Information
NCT ID
NCT01562782
First Posted
March 22, 2012
Last Updated
June 14, 2019
Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01562782
Brief Title
Change of Fructose to Fat in South Asians
Official Title
Fructose-induced Hepatic De Novo Lipogenesis in South Asians
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2, 2012 (Actual)
Primary Completion Date
October 10, 2013 (Actual)
Study Completion Date
October 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Triglycerides, Diabetes, Cardiovascular Disease, Dyslipidemia
Keywords
Elevated triglycerides, Diabetes Mellitus, Dyslipidemia, Lipid Metabolic Disorders, Body Weight
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
South Asians
Arm Type
Experimental
Arm Description
Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage.
Arm Title
Caucasians
Arm Type
Active Comparator
Arm Description
Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage.
Intervention Type
Other
Intervention Name(s)
Fructose + Glucose Beverage
Intervention Description
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 Measure Information:
Title
Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
Description
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.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Fold Changes in VLDL Triglycerides in South Asians and Caucasians
Description
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.
Time Frame
4 hours
Title
Peak Glucose Levels in 2 Study Groups
Description
A comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose.
Time Frame
1 hour
Title
Peak Insulin Levels in 2 Study Groups
Description
A comparison of the mean peak insulin level at one hour in each group. Insulin is expected to increase after ingestion of glucose/fructose.
Time Frame
1 hour
Title
Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups
Description
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.
Time Frame
2 hours
Title
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
Description
Correlations between fold change in VLDL TG palmitate at 4 hours with other biomarkers of carbohydrate and fat metabolism in each study group.
Time Frame
4 hours
Title
Fold Changes in Triglycerides in 2 Study Groups
Description
1) A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.
Time Frame
4 hours
Title
Peak Lactate Levels in 2 Study Groups
Description
A comparison of peak levels of lactate (at one hour). Lactate is expected to increase after ingestion of glucose/fructose.
Time Frame
1 hour
Title
Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups
Description
A comparison of the nadir level of non-esterified fatty acids (NEFA at 2 hours). NEFA are expected to decrease.
Time Frame
2 hours
Title
Peak Glucose in 2 Study Groups
Description
A comparison of peak levels of glucose at 1 hour. Glucose is expected to increase after ingestion of glucose/fructose.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Hudgins, MD
Organizational Affiliation
The Rogosin Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College Clinical and Translational Science Center (CTSC)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Change of Fructose to Fat in South Asians
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