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

Fasting Clinical Trial

— E228  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201549
• Other study ID #: 2017P000053
• Status: Completed
• Phase: N/A
• Start date: July 30, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasting

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum FGF21 levels		2 weeks