FastingNCT00968747
Regulation of FGF21 by Nutritional Challenges
A study testing Fasting, Diet and oral carbohydrate challenge in people with Fasting and Non-alcoholic Fatty Liver Disease (NAFLD), run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue. This study will have several aims. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Fasting, Diet and oral carbohydrate challenge
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 31 Jul 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
- Age 18-50 years
- Body Mass Index 21-26 kg/m^2
- Ability to give informed consent
- Ability to follow verbal and written instructions in English
- Age 18-60
- BMI 25-45 kg/m^2
Show all 9Show fewer
- Known nonalcoholic fatty liver disease based on liver biopsy
- Ability to give informed consent
- Ability to follow verbal and written instructions in English
Who cannot join
- Type 1 or Type 2 diabetes mellitus diagnosed according to the American Diabetes Association criteria
- Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
- Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
- Recent weight change (>3 kg within 6 months of screening visit)
- Malignancy treated with chemotherapy within past 3 years
- History of depression, psychosis, or other psychiatric illness requiring hospitalization
Show all 40Show fewer
- History of hyperthyroidism
- Renal insufficiency (creatinine clearance < 50 ml/min)
- Transaminases > 2X above the normal range
- Known liver disease
- Pregnancy within 12 months of screening visit
- Lactation within 12 months of screening visit
- Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
- History of an eating disorder (anorexia, bulimia, or laxative abuse)
- History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- New diagnosis of hypothyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
- History of alcohol abuse within the past 3 years
- History of keloid formation
- History of allergy to lidocaine or marcaine
- Use of plavix, coumadin, or heparin
- 72-hour fast or hypocaloric diet in subjects with non-alcoholic fatty liver disease (NAFLD) (Study Arms B \& C):
- Type I diabetes mellitus diagnosed according to the American Diabetes Association criteria or Type II diabetes mellitus with A1c > 7.5% or taking metformin or thiazolidinediones
- Coronary Heart Disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
- Uncontrolled hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
- Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
- Recent weight change (> 3 kg within 6 months of screening visit)
- Malignancy treated with chemotherapy within the past 3 years
- History of depression, psychosis, or other psychiatric illness requiring hospitalization
- History of hypo or hyperthyroidism
- Renal insufficiency (creatinine clearance < 50 ml/min)
- Pregnancy within 12 months of screening visit
- Lactation within 12 months of screening visit
- Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
- History of an eating disorder (anorexia, bulimia, or laxative abuse)
- History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- New diagnosis of hypo or hyperthyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
- History of alcohol abuse within the past 3 years
- Cardiac pacemaker or aneurysm clips
- Metal implants in the body (pins, plates, shrapnel, intact bullets, IUD)
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Effect of Acute Nutritional Challenges on FGF21 Levels in Humans
The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue.
This study will have several aims.
Read more
One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21 (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken. Two fat samples will be taken prior to and at the end of the fast. A subset of participants will also have two MRIs, one prior to and one at the end of the fast. We will study healthy adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING
Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for weight measurements. Blood will be drawn before and after the weight loss. Participants will also have an MRI before and after the weight loss.
THIS ARM IS CURRENTLY NOT RECRUITING
Another aim of the study is to examine the effect of acute ingestion of glucose, fructose, and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.
THIS ARM IS CURRENTLY RECRUITING
Read the 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 5 different sweet beverages, separated by 2 weeks.
- Conditions
- Fasting, Non-alcoholic Fatty Liver Disease (NAFLD)
- Being tested
- Fasting, Diet, oral carbohydrate challenge
- Keywords
- Fasting, Fast, healthy, diet, study, manipulation, dietary, FGF21, Fibroblast growth factor, PTRF, Polymerase 1 and transcript release factor, adipose, fat, blood, inpatient, outpatient, NAFLD, metabolism
- Medical subject headings
- Fasting, Non-alcoholic Fatty Liver Disease, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Participants will fast for 72 hours and may consume only water and vitamins.
FastingBehavioural
Participants will fast for 72 hours and may consume only water and vitamins.
DietBehavioural
Participants will follow a low-calorie diet until they lose 3-5% of their body weight.
oral carbohydrate challengeDietary supplement
Participants will fast for 16 hours and then drink a beverage containing glucose, fructose or a mixture of both
| Study group | Role | What they receive |
|---|---|---|
| Fasting (Healthy). | Experimental | Participants will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. Blood samples will be collected daily and two fat samples will be obtained by a trained surgeon. (We are no longer recruiting for Study Arm A). Receives: Behavioral: Fasting |
| Fasting (NAFLD) | Experimental | Participants with liver-biopsy diagnosed non-alcoholic fatty liver disease (NAFLD) will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. Blood samples will be collected daily, and participants will have an MRI before and after the fast. Receives: Behavioral: Fasting |
| Hypocaloric diet (NAFLD) | Experimental | Participants will follow a low-calorie diet until they lose 3-5% of their body weight. Participants will have weekly outpatient visits at Beth Israel Deaconess Medical Center in Boston, MA for weight measurements. Participants will have blood drawn before and after the diet. Participants will also have an MRI before and after the diet. Receives: Behavioral: Diet |
| Oral carbohydrate challenge | Experimental | Participants will fast for 16 hours overnight then ingest drinks containing fructose, glucose or a mixture of fructose and glucose. Blood will be drawn postprandially at specified timepoints for up to 5 hours Receives: Dietary Supplement: oral carbohydrate challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast Growth Factor 21 levels in serum and fat
Change in FGF21 levels following nutritional intervention.
Measured: before and after dietary intervention
Secondary outcomes (5)
Polymerase 1 and Transcript Release Factor levels in fat
Measured: Prior to fasting and at the end of the 72-hour fast in healthy participants and participants with NAFLD
Urine and serum ketosis
Measured: Daily during the 72-hour fast for healthy participants and participants with NAFLD
Hepatic fat content
Measured: Before and after the 72-hour fast or hypocaloric diet in participants with NAFLD
change in serum triglyceride levels
Measured: following fructose and glucose ingestion
change in glucose and insulin levels
Measured: following fructose and glucose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJul 2009
- Primary completion31 Jul 2023
- Study completion31 Jul 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- Investigators
- Jody Dushay, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968747
- Sponsor's protocol ID
- 2009P-000073
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2009
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 Effect of Acute Nutritional Challenges on FGF21 Levels in Humans
- ClinicalTrials.gov ID
- NCT00968747
- Acronym / sponsor ID
- 2009P-000073
- Conditions
- Fasting, Non-alcoholic Fatty Liver Disease (NAFLD)
- Keywords
- Fasting, Fast, healthy, diet, study, manipulation, dietary, FGF21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 31 Aug 2009 (estimated)
- 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 purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue.
This study will have several aims.
One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21 (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken. Two fat samples will be taken prior to and at the end of the fast. A subset of participants will also have two MRIs, one prior to and one at the end of the fast. We will study healthy adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING
Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for weight measurements. Blood will be drawn before and after the weight loss. Participants will also have an MRI before and after the weight loss.
THIS ARM IS CURRENTLY NOT RECRUITING
Another aim of the study is to examine the effect of acute ingestion of glucose, fructose, and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.
THIS ARM IS CURRENTLY RECRUITING
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 5 different sweet beverages, separated by 2 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fasting (Healthy). | Experimental | Behavioral: FastingParticipants will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. Blood samples will be collected daily and two fat samples will be obtained by a trained surgeon. (We are no longer recruiting for Study Arm A). |
| Fasting (NAFLD) | Experimental | Behavioral: FastingParticipants with liver-biopsy diagnosed non-alcoholic fatty liver disease (NAFLD) will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. Blood samples will be collected daily, and participants will have an MRI before and after the fast. |
| Hypocaloric diet (NAFLD) | Experimental | Behavioral: DietParticipants will follow a low-calorie diet until they lose 3-5% of their body weight. Participants will have weekly outpatient visits at Beth Israel Deaconess Medical Center in Boston, MA for weight measurements. Participants will have blood drawn before and after the diet. Participants will also have an MRI before and after the diet. |
| Oral carbohydrate challenge | Experimental | Dietary Supplement: oral carbohydrate challengeParticipants will fast for 16 hours overnight then ingest drinks containing fructose, glucose or a mixture of fructose and glucose. Blood will be drawn postprandially at specified timepoints for up to 5 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-50 years
- Body Mass Index 21-26 kg/m^2
- Ability to give informed consent
- Ability to follow verbal and written instructions in English
- Age 18-60
Key exclusion criteria (40 listed)
- Type 1 or Type 2 diabetes mellitus diagnosed according to the American Diabetes Association criteria
- Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
- Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
- Recent weight change (>3 kg within 6 months of screening visit)
- Malignancy treated with chemotherapy within past 3 years
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 |
|---|---|---|
| FastingParticipants will fast for 72 hours and may consume only water and vitamins. | Behavioural | Fasting (Healthy). |
| FastingParticipants will fast for 72 hours and may consume only water and vitamins. | Behavioural | Fasting (Healthy)., Fasting (NAFLD) |
| DietParticipants will follow a low-calorie diet until they lose 3-5% of their body weight. | Behavioural | Hypocaloric diet (NAFLD) |
| oral carbohydrate challengeParticipants will fast for 16 hours and then drink a beverage containing glucose, fructose or a mixture of both | Dietary supplement | Oral carbohydrate challenge |
Primary outcome
Fibroblast Growth Factor 21 levels in serum and fat
Time frame: before and after dietary intervention
Change in FGF21 levels following nutritional intervention.
5 secondary outcomes
Polymerase 1 and Transcript Release Factor levels in fat
Time frame: Prior to fasting and at the end of the 72-hour fast in healthy participants and participants with NAFLD
Urine and serum ketosis
Time frame: Daily during the 72-hour fast for healthy participants and participants with NAFLD
Hepatic fat content
Time frame: Before and after the 72-hour fast or hypocaloric diet in participants with NAFLD
change in serum triglyceride levels
Time frame: following fructose and glucose ingestion
change in glucose and insulin levels
Time frame: following fructose and glucose ingestion
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.
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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.
Jody Dushay, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting, Diet and oral carbohydrate challenge in people with Fasting and Non-alcoholic Fatty Liver Disease (NAFLD), 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 9 inclusion and 40 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?
Fibroblast Growth Factor 21 levels in serum and fat (time frame: before and after dietary intervention). 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.