The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
Not Applicable
Completed
- Conditions
- Fasting
- Interventions
- Dietary Supplement: oral fructose challenge
- Registration Number
- NCT03201549
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Ages 18-60
- 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
- Fasting blood glucose >100
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description healthy oral fructose challenge healthy volunteers will ingest fructose and have FGF21 levels measured
- Primary Outcome Measures
Name Time Method Change in serum FGF21 levels 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States