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Fructose-Induced Palmitate Synthesis in Overweight Subjects

Fructose-Induced Palmitate Synthesis in Overweight Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00535535
Enrollment
15
Registered
2007-09-26
Start date
2007-08-31
Completion date
2011-12-31
Last updated
2013-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes, Elevated Triglycerides

Keywords

Elevated triglycerides, Diabetes, Cardiovascular disease

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.

Interventions

DIETARY_SUPPLEMENTFructose

Fructose, 0.5 g/kg

DIETARY_SUPPLEMENTFructose and Glucose

Fructose:Glucose 1:1, 1 g/kg

Sponsors

The Rogosin Institute
CollaboratorOTHER
Rockefeller University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026