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Fructose-Induced Palmitate Synthesis in Overweight Subjects

Primary Purpose

Elevated Triglycerides, Diabetes, Cardiovascular Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fructose
Fructose and Glucose
Fructose and Glucose
Sponsored by
Rockefeller University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elevated Triglycerides focused on measuring Elevated triglycerides, Diabetes, Cardiovascular disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rockefeller University

Outcomes

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

Full Information

First Posted
September 24, 2007
Last Updated
September 19, 2013
Sponsor
Rockefeller University
Collaborators
The Rogosin Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00535535
Brief Title
Fructose-Induced Palmitate Synthesis in Overweight Subjects
Official Title
Fructose-Induced Palmitate Synthesis in Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University
Collaborators
The Rogosin Institute

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Triglycerides, Diabetes, Cardiovascular Disease
Keywords
Elevated triglycerides, Diabetes, Cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Fructose
Intervention Description
Fructose, 0.5 g/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructose and Glucose
Intervention Description
Fructose:Glucose 1:1, 1 g/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructose and Glucose
Intervention Description
Fructose:Glucose 1:1, 2g/kg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Linear regression analysis of the relationship between the iAUC in VLDL TG palmitate after oral fructose and markers of carbohydrate and lipid flux

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa C Hudgins, MD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21252253
Citation
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.
Results Reference
derived

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Fructose-Induced Palmitate Synthesis in Overweight Subjects

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