The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
NCT ID: NCT03201549
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-07-30
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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healthy
healthy volunteers will ingest fructose and have FGF21 levels measured
oral fructose challenge
Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.
Interventions
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oral fructose challenge
Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.
Eligibility Criteria
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Inclusion Criteria
* BMI 19-25 kg/m2; 19-23 for Asian subjects
* Stable weight (variation \< 3 kg within 6 months of screening visit)
* Ability to give informed consent in English
* Use of medically approved form of contraception
Exclusion Criteria
* Hemoglobin A1C% \> 6.5%
* Fasting triglycerides \>150
* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
* Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
* Uncontrolled hypertension (BP \> 160/100 mmHg on or off antihypertensive medication) intravenous drug use
* Recent weight loss (\> 3 kg within 6 months of the screening visit)
* Gastroparesis
* Inflammatory or irritable bowel disease
* Malignancy treated with chemotherapy within the past 3 years
* Depression or psychosis requiring hospitalization
* Renal insufficiency (creatinine clearance \< 40 ml/min)
* Transaminases \> 2x above the normal range
* Known liver disease
* Pregnancy within 6 months of the screening visit
* Lactation
* Failure to use medically approved contraceptive methods
* History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
* Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit
* History of alcohol abuse within the past 5 years
* Fructose intolerance
Exclusionary medications:
* Oral steroids
* Metformin
* Weight loss medications including nonprescription supplements
18 Years
60 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Jody Dushay
Assistant Professor of Medicine
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2017P000053
Identifier Type: -
Identifier Source: org_study_id
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