NCT03201549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

5.9 years

First QC Date

June 27, 2017

Last Update Submit

August 9, 2023

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

  • Change in serum FGF21 levels

    2 weeks

Study Arms (1)

healthy

EXPERIMENTAL

healthy volunteers will ingest fructose and have FGF21 levels measured

Dietary Supplement: oral fructose challenge

Interventions

oral fructose challengeDIETARY_SUPPLEMENT

Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.

healthy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 28, 2017

Study Start

July 30, 2017

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)