Fructose-Induced Palmitate Synthesis in Overweight Subjects

Sponsor

Rockefeller University (Other)

Overall Status

Completed

CT.gov ID

NCT00535535

Collaborator

The Rogosin Institute (Other)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Elevated Triglycerides Diabetes Cardiovascular Disease	Dietary Supplement: Fructose Dietary Supplement: Fructose and Glucose Dietary Supplement: Fructose and Glucose	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single

Primary Purpose:

Prevention

Official Title:

Fructose-Induced Palmitate Synthesis in Overweight Subjects

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Outcome Measures

Primary Outcome Measures

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. []

Secondary Outcome Measures

Linear regression analysis of the relationship between the iAUC in VLDL TG palmitate after oral fructose and markers of carbohydrate and lipid flux []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females, 18-75 years of age
Body mass index (BMI) 25-35 and within 10% of maximum weight
Willing and able to stop fish oil, psyllium, other non-prescribed vitamins/supplements for 1 week prior to study until completion of study
Willing to not drink alcohol for 24 h before each day of blood sampling

Exclusion Criteria:

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 GI dysfunction or malabsorption
History of fasting TG >800 mg/dl
History of ethanol abuse (current intake >2 drinks/d) 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