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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201549
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : June 28, 2017
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

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

Condition or disease Intervention/treatment Phase
Fasting Dietary Supplement: oral fructose challenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
Actual Study Start Date : July 30, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

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.




Primary Outcome Measures :
  1. Change in serum FGF21 levels [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201549


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03201549    
Other Study ID Numbers: 2017P000053
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No