Trial Outcomes & Findings for Change of Fructose to Fat in South Asians (NCT NCT01562782)
NCT ID: NCT01562782
Last Updated: 2024-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
4 hours
Results posted on
2024-03-12
Participant Flow
Between 4/2012 and 10/2013 fifteen South Asians and 15 Caucasians were studied as outpatients at the Weill Cornell Medical College Clinical and Translational Science Center (CTSC).
At the CTSC clinic, consented volunteers had their medical history reviewed and a physical exam performed. A fasting blood sample was obtained to screen for lipid and biochemical abnormalities, thyroid and liver disease, anemia, pregnancy and diabetes/glucose intolerance.
Participant milestones
| Measure |
Caucasians
Control group: The arm is an oral sugar challenge with blood sampling over 4 hours.
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.
|
South Asians
South Asian group: The arm is an oral sugar challenge with blood sampling over 4 hours.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Caucasians
Control group: The arm is an oral sugar challenge with blood sampling over 4 hours.
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.
|
South Asians
South Asian group: The arm is an oral sugar challenge with blood sampling over 4 hours.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
screen failure
|
1
|
2
|
Baseline Characteristics
Change of Fructose to Fat in South Asians
Baseline characteristics by cohort
| Measure |
Caucasian
n=15 Participants
Control group: The arm is an oral sugar challenge with blood sampling over 4 hours.
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.
|
South Asians
n=15 Participants
Experimental group: The arm is an oral sugar challenge with blood sampling over 4 hours.
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 3 • n=5 Participants
|
26 years
STANDARD_DEVIATION 5 • n=7 Participants
|
27 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursFold 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.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
|
1.24 fold change
Standard Deviation 0.87
|
1.85 fold change
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 4 hours1\) A comparison of the fold changes in very low density lipoprotein triglycerides (VLDL TG)in the 2 study groups between 0 and 4 hours.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Fold Changes in VLDL Triglycerides in South Asians and Caucasians
|
1.05 fold change
Standard Deviation 0.56
|
1.44 fold change
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: 1 hourA comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Peak Glucose Levels in 2 Study Groups
|
5.16 mmol/L
Standard Deviation 1.83
|
5.61 mmol/L
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: 1 hourA comparison of the mean peak insulin level at one hour in each group. Insulin is expected to increase after ingestion of glucose/fructose.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Peak Insulin Levels in 2 Study Groups
|
93 IU/L
Standard Deviation 78
|
111 IU/L
Standard Deviation 45
|
SECONDARY outcome
Timeframe: 2 hoursA 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.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups
|
277 ng/L
Standard Deviation 90
|
274 ng/L
Standard Deviation 99
|
SECONDARY outcome
Timeframe: 4 hoursCorrelations between fold change in VLDL TG palmitate at 4 hours with other biomarkers of carbohydrate and fat metabolism in each study group.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmitate 4h: VLDL TG 0h
|
0.1137 r (correlation coefficient)
|
0.0127 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmita 4h:fold change VLDL TG
|
0.3339 r (correlation coefficient)
|
0.3149 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmitate 4h:total TG 0h
|
0.2320 r (correlation coefficient)
|
0.0359 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmitat: fold change total TG
|
0.3340 r (correlation coefficient)
|
0.3290 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmitate 4h:cholesterol 0h
|
-0.0327 r (correlation coefficient)
|
-0.3910 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmitat 4h:HDL cholesterol 0h
|
0.0883 r (correlation coefficient)
|
-0.3743 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmita 4h:apolipoprotein B 0h
|
0.0587 r (correlation coefficient)
|
-0.1459 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palm 4h:LDL particle number 0h
|
-0.0045 r (correlation coefficient)
|
-0.0849 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:LDL size 0h
|
0.1508 r (correlation coefficient)
|
0.0359 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VLDL TG palmitate 4h:glucose 0h
|
-0.2444 r (correlation coefficient)
|
0.0188 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:glucose AUC
|
0.2677 r (correlation coefficient)
|
-0.1569 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:insulin 0h
|
-0.2778 r (correlation coefficient)
|
-0.1151 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:insulin AUC
|
0.1886 r (correlation coefficient)
|
-0.0070 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:NEFA 0h
|
0.0241 r (correlation coefficient)
|
-0.5689 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:NEFA nadir 2h
|
0.1319 r (correlation coefficient)
|
-0.6151 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:lactate 0h
|
0.1082 r (correlation coefficient)
|
0.4382 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:lactate peak 1h
|
0.1393 r (correlation coefficient)
|
-0.1953 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:GIP 0h
|
-0.3237 r (correlation coefficient)
|
-0.2644 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:GIP peak 2h
|
0.2889 r (correlation coefficient)
|
-0.0453 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:HOMA-R 0h
|
-0.2892 r (correlation coefficient)
|
-0.1104 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:HOMA-B% 0h
|
-0.2347 r (correlation coefficient)
|
0.2959 r (correlation coefficient)
|
|
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
fold change VDLD TG palmitate 4h:hsCRP 0h
|
0.0278 r (correlation coefficient)
|
0.2463 r (correlation coefficient)
|
SECONDARY outcome
Timeframe: 4 hours1\) A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Fold Changes in Triglycerides in 2 Study Groups
|
1.05 fold change
Standard Deviation 0.56
|
1.43 fold change
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: 1 hourA comparison of peak levels of lactate (at one hour). Lactate is expected to increase after ingestion of glucose/fructose.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Peak Lactate Levels in 2 Study Groups
|
3.43 mmol/L
Standard Deviation 1.15
|
3.91 mmol/L
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 2 hoursA comparison of the nadir level of non-esterified fatty acids (NEFA at 2 hours). NEFA are expected to decrease.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups
|
0.09 mmol/L
Standard Deviation 0.05
|
0.09 mmol/L
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 1 hourA comparison of peak levels of glucose at 1 hour. Glucose is expected to increase after ingestion of glucose/fructose.
Outcome measures
| Measure |
Caucasians
n=15 Participants
Caucasian control group
|
South Asians
n=15 Participants
South Asian experimental group
|
|---|---|---|
|
Peak Glucose in 2 Study Groups
|
5.16 mmol/L
Standard Deviation 1.83
|
5.61 mmol/L
Standard Deviation 1.94
|
Adverse Events
Caucasians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
South Asians
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caucasians
n=15 participants at risk
Caucasian control group
|
South Asians
n=15 participants at risk
South Asian experimental group
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/15 • 4 hours per participant.
|
6.7%
1/15 • Number of events 1 • 4 hours per participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place