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Completed

NCT Number: NCT00535535

Fructose-Induced Palmitate Synthesis in Overweight Subjects

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.

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Key information

Conditions

Elevated Triglycerides Cardiovascular Disease Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rockefeller University

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fructose

Dietary Supplement

Fructose, 0.5 g/kg

Fructose and Glucose

Dietary Supplement

Fructose:Glucose 1:1, 1 g/kg

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

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Collaborators

  • The Rogosin Institute

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2007
Registry last updated
Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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