The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans (E228)

Beth Israel Lahey Health

Status: Completed

Conditions: Fasting

Treatments: Dietary Supplement: oral fructose challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT03201549

2017P000053

Details and patient eligibility

About

The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

healthy

Experimental group

Description:

healthy volunteers will ingest fructose and have FGF21 levels measured

Treatment:

Dietary Supplement: oral fructose challenge