The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans

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