FGF21 and Fructose Challenge in Humans

Not Applicable

Completed

• Conditions: Fasting
• Interventions: Dietary Supplement: oral carbohydrate challenge

• Registration Number: NCT02884791
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.

Detailed Description

Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 10 different sweet beverages, separated by 2 weeks.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting (Healthy)	oral carbohydrate challenge	Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks.
Fasting (metabolic syndrome)	oral carbohydrate challenge	Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Fibroblast Growth Factor 21 levels in human serum	5 hours

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States