MedDataX Logo

Fructose-Induced Palmitate Synthesis in Overweight Subjects

NCT ID: NCT00535535

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elevated Triglycerides Diabetes Cardiovascular Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Elevated triglycerides Diabetes Cardiovascular disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fructose

Fructose, 0.5 g/kg

Intervention Type DIETARY_SUPPLEMENT

Fructose and Glucose

Fructose:Glucose 1:1, 1 g/kg

Intervention Type DIETARY_SUPPLEMENT

Fructose and Glucose

Fructose:Glucose 1:1, 2g/kg

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Rogosin Institute

OTHER

Sponsor Role collaborator

Rockefeller University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa C Hudgins, MD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rockefeller University

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21252253 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LHU-0616

Identifier Type: -

Identifier Source: org_study_id