A Phase 1 interventional study of Fructose and Fructose and Glucose in Elevated Triglycerides, Diabetes and Cardiovascular Disease, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-23.
Sponsored by Rockefeller University · Phase 1, Interventional, and Prevention
Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver from each single oral dose of fructose (0.5 g/kg), fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose and 2) show a dose-response. The lipogenic responses will be compared and correlated with markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results will serve as a guide to the development of a new outpatient probe of the de novo lipogenic pathway in subjects who vary in their lipogenic response to oral fructose. These studies should ultimately yield valuable new information about the mechanisms linking dietary carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.
4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's planned enrollment of 15 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
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Exclusion Criteria:
Fructose, 0.5 g/kg
Fructose:Glucose 1:1, 1 g/kg
Fructose:Glucose 1:1, 2g/kg
A comparison of the iAUC in VLDL TG palmitate 4 hours after F:G1:1, 1g/kg, vs. 1) fructose 0.5g/kg, and 2) F:G:1:1, 2g/kg.
Linear regression analysis of the relationship between the iAUC in VLDL TG palmitate after oral fructose and markers of carbohydrate and lipid flux
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Rockefeller University