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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03201549

Acronym

E228

Enrollment

Registered

2017-06-28

Start date

2017-07-30

Completion date

2023-06-30

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting

Brief summary

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

Interventions

DIETARY_SUPPLEMENToral fructose challenge

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in serum FGF21 levels	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026