Fructose-Induced Palmitate Synthesis in Overweight Subjects

NCT00535535 | Completed Phase 1

• 1 other identifier: LHU-0616
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Triglycerides; Diabetes; Cardiovascular Disease

Keywords

Elevated triglycerides; Diabetes; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Fructose DIETARY_SUPPLEMENT

Fructose, 0.5 g/kg

Fructose and Glucose DIETARY_SUPPLEMENT

Fructose:Glucose 1:1, 1 g/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead
• The Rogosin Institute: collaborator

Study Sites (1)

Rockefeller University

New York, New York, 10021, United States

Location

Related Publications (1)

• Hudgins LC, Parker TS, Levine DM, Hellerstein MK. A dual sugar challenge test for lipogenic sensitivity to dietary fructose. J Clin Endocrinol Metab. 2011 Mar;96(3):861-8. doi: 10.1210/jc.2010-2007. Epub 2011 Jan 20.

  PMID: 21252253 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia; Diabetes Mellitus; Cardiovascular Diseases

Interventions

Fructose; Glucose

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Lisa C Hudgins, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

US (1)