FastingE228NCT03201549
The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
A study testing oral fructose challenge in people with Fasting, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- oral fructose challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.
- Conditions
- Fasting
- Being tested
- oral fructose challenge
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy | Experimental | healthy volunteers will ingest fructose and have FGF21 levels measured Receives: Dietary Supplement: oral fructose challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum FGF21 levels
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start30 Jul 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jody Dushay, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201549
- Sponsor's protocol ID
- 2017P000053
- Acronym
- E228
- Status last verified
- Aug 2023
- First submitted
- 27 Jun 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
- ClinicalTrials.gov ID
- NCT03201549
- Acronym / sponsor ID
- E228 / 2017P000053
- Conditions
- Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy | Experimental | Dietary Supplement: oral fructose challengehealthy volunteers will ingest fructose and have FGF21 levels measured |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral fructose challengeParticipants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage. | Dietary supplement | healthy |
Primary outcome
Change in serum FGF21 levels
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral fructose challenge in people with Fasting, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum FGF21 levels (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.