The Effects of Increased Fructose Ingestion on FGF-21 Lev... | NCT03201549

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

NCT03201549

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Aug 14, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Fasting

Interventions

oral fructose challenge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2017Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Jun 27, 2017

First Submission Date that Met QC Criteria

Jun 27, 2017

First Posted Date

Jun 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2023

Last Update Posted Date

Aug 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy	Experimental	healthy volunteers will ingest fructose and have FGF21 levels measured	Dietary Supplement: oral fructose challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral fructose challenge	Dietary Supplement	Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.	healthy

Measure	Description	Time Frame
Change in serum FGF21 levels		2 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005247	Feeding Behavior
D001519	Behavior