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

August 9, 2023 updated by: Jody Dushay, Beth Israel Deaconess Medical Center
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy
healthy volunteers will ingest fructose and have FGF21 levels measured
Dietary supplement: oral fructose challenge
Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum FGF21 levels
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2017

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2017P000053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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