Fructose-Induced Palmitate Synthesis in Overweight Subjects

Diabetes Clinical Trial

Official title:

Fructose-Induced Palmitate Synthesis in Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535535
• Other study ID #: LHU-0616
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2007
• Last updated: September 19, 2013
• Start date: August 2007
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Elevated Triglycerides
• Hypertriglyceridemia

Intervention

Dietary Supplement:
• Fructose
Fructose, 0.5 g/kg
• Fructose and Glucose
Fructose:Glucose 1:1, 1 g/kg
• Fructose and Glucose
Fructose:Glucose 1:1, 2g/kg

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	The Rogosin Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Linear regression analysis of the relationship between the iAUC in VLDL TG palmitate after oral fructose and markers of carbohydrate and lipid flux