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Fructose-Induced Palmitate Synthesis in Overweight Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535535
First Posted: September 26, 2007
Last Update Posted: September 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Rogosin Institute
Information provided by (Responsible Party):
Rockefeller University
  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
Primary Purpose: Prevention
Official Title: Fructose-Induced Palmitate Synthesis in Overweight Subjects

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 24, 2007
First Posted: September 26, 2007
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by Rockefeller University:
Elevated triglycerides
Diabetes
Cardiovascular disease

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