FGF21 and Fructose Challenge in Humans

Fibroblast Growth Factor 21 and Fructose Challenge in Humans

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02884791

Enrollment

Registered

2016-08-31

Start date

2016-02-29

Completion date

2023-05-30

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting

Keywords

FGF21, Fibroblast growth factor, fructose

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.

Interventions

DIETARY_SUPPLEMENToral carbohydrate challenge

Participants will fast for 8 hours and then drink a beverage containing fructose.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

for lean subjects: * Men and women 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 * Ability to follow verbal and written instructions in English * Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) Specific

Exclusion criteria

for lean subjects: * Fasting blood glucose \>100; 2 hr OGTT blood glucose \>140 * Fasting triglycerides \>150 Inclusion criteria for metabolic syndrome subjects: 3 or more of the following (based on joint scientific statement by Alberti et al, 2009: * Fasting triglycerides \>150 mg/dl (or on treatment for elevated triglycerides) * HDL cholesterol \<40 mg/dl in men or \<50 mg/dl in women * Blood pressure \> 130/85 (or antihypertensive treatment in a subject with history of hypertension) * Fasting BG \>100 * Elevated waist circumference \*\* see below for race and ethnic specifications Men Women * Asian or Central, South or Native American \> 90 cm \> 80 cm * Non-Asian, Non-Latino United States \> 102 cm \> 88 cm General

Design outcomes

Primary

Measure	Time frame
Change in Fibroblast Growth Factor 21 levels in human serum	5 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026