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

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

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Key information

Conditions

Fasting Behavior Feeding Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral fructose challenge

Dietary Supplement

Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.

Primary outcomes

Change in serum FGF21 levels

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Acronym: E228

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Jun 28, 2017
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed