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Fructose-Induced Palmitate Synthesis in Overweight Subjects

This study has been completed.
Sponsor:
Collaborator:
The Rogosin Institute
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00535535
First received: September 24, 2007
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Elevated Triglycerides
Diabetes
Cardiovascular Disease
 Dietary Supplement: Fructose
Dietary Supplement: Fructose and Glucose
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Fructose-Induced Palmitate Synthesis in Overweight Subjects

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Rockefeller University:

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

Estimated Enrollment: 15
Study Start Date: August 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Fructose
    Fructose, 0.5 g/kg
    Dietary Supplement: Fructose and Glucose
    Fructose:Glucose 1:1, 1 g/kg
    Dietary Supplement: Fructose and Glucose
    Fructose:Glucose 1:1, 2g/kg
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535535

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
The Rogosin Institute
Investigators
Principal Investigator: Lisa C Hudgins, MD Rockefeller University
  More Information

No publications provided by Rockefeller University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00535535     History of Changes
Other Study ID Numbers: LHU-0616
Study First Received: September 24, 2007
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Elevated triglycerides
Diabetes
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Hypertriglyceridemia
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013