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CompletedNCT03201549E228Updated Aug 14, 2023

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

An interventional study of oral fructose challenge in Fasting, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Fasting
03

In context

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    healthy

    healthy volunteers will ingest fructose and have FGF21 levels measured

    Dietary Supplement: oral fructose challenge

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.

06

What researchers measure

Primary outcomes

  1. Change in serum FGF21 levels

    Time frame: 2 weeks

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03201549
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Jody Dushay (Assistant Professor of Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Jun 28, 2017
Start date
Jul 30, 2017
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Aug 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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