Metabolic RegulationNCT00476125
Effects of Dietary Manipulation on Metabolism in Healthy Adults
A study testing Dietary manipulation ketogenic diet, Dietary Manipulation - 12 day ketogenic diet and 16 Hour Fast in people with Metabolic Regulation and Fasting, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Regulation, Fasting, Ketogenic Diet
- What is being tested?
- Dietary manipulation ketogenic diet, Dietary Manipulation - 12 day ketogenic diet and 16 Hour Fast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 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
- Men and women ages 18-60
- BMI 21-28 kg/m2
- 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)
Who cannot join
- 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 > 150/90 mmHg on or off antihypertensive medication)
- Dyslipidemia
- Tobacco, marijuana or intravenous drug use
- Shift workers (night shift or alternating day/night shifts)
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- Recent weight loss (> 3 kg within 6 months of the screening visit)
- Gastroparesis
- Inflammatory bowel disease
- Malignancy treated with chemotherapy within the past 3 years
- History of pancreatitis
- Depression or psychosis
- Renal insufficiency (creatinine clearance < 50 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 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
- History of alcohol abuse within the past 5 years
- Seizure disorder
- Gout
- Kidney stones
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and diet-induced ketosis.
Read the detailed description
There is scant data regarding the metabolic events that occur in humans during ketosis which may be brought about by fasting or ingestion of diets low in carbohydrate.
We aim to employ both fasting and dietary manipulation in order to bring about a ketotic state in healthy human adults. During the study blood levels of key metabolic regulators will be monitored 1) during a 16 hour fast followed by re-feeding and 2) during dietary induction of ketosis followed by re-feeding with a standard meal.
- Conditions
- Metabolic Regulation, Fasting, Ketogenic Diet
- Being tested
- Dietary manipulation ketogenic diet, Dietary Manipulation - 12 day ketogenic diet, 16 Hour Fast
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary manipulation ketogenic dietBehavioural
Subjects will consume a ketogenic diet for 3 days.
Dietary Manipulation - 12 day ketogenic dietBehavioural
Subjects will consume a ketogenic diet for 12 days.
16 Hour FastBehavioural
Subjects will fast for 16 hours.
| Study group | Role | What they receive |
|---|---|---|
| 3 day ketogenic diet | Experimental | Not described Receives: Behavioral: Dietary manipulation ketogenic diet |
| 12 day ketogenic diet | Experimental | Not described Receives: Behavioral: Dietary Manipulation - 12 day ketogenic diet |
| 16 hour fast | Experimental | Not described Receives: Behavioral: 16 Hour Fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating plasma levels of key metabolic regulators
Measured: 1 week
Secondary outcomes (1)
A secondary outcome is change in energy expenditure with diet-induced ketosis.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMar 2008
- Primary completionAug 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic RegulationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Eleftheria Maratos Flier, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476125
- Sponsor's protocol ID
- 2007P000017
- Status last verified
- Aug 2023
- First submitted
- 17 May 2007
- 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
- Effects of Dietary Manipulation on Metabolism in Healthy Adults
- ClinicalTrials.gov ID
- NCT00476125
- Acronym / sponsor ID
- 2007P000017
- Conditions
- Metabolic Regulation, Fasting, Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 21 May 2007 (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.
This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and diet-induced ketosis.
Detailed description
There is scant data regarding the metabolic events that occur in humans during ketosis which may be brought about by fasting or ingestion of diets low in carbohydrate.
We aim to employ both fasting and dietary manipulation in order to bring about a ketotic state in healthy human adults. During the study blood levels of key metabolic regulators will be monitored 1) during a 16 hour fast followed by re-feeding and 2) during dietary induction of ketosis followed by re-feeding with a standard meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 day ketogenic diet | Experimental | Behavioral: Dietary manipulation ketogenic diet |
| 12 day ketogenic diet | Experimental | Behavioral: Dietary Manipulation - 12 day ketogenic diet |
| 16 hour fast | Experimental | Behavioral: 16 Hour Fast |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women ages 18-60
- BMI 21-28 kg/m2
- 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
Key exclusion criteria (25 listed)
- 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 > 150/90 mmHg on or off antihypertensive medication)
- Dyslipidemia
- Tobacco, marijuana or intravenous drug use
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 |
|---|---|---|
| Dietary manipulation ketogenic dietSubjects will consume a ketogenic diet for 3 days. | Behavioural | 3 day ketogenic diet |
| Dietary Manipulation - 12 day ketogenic dietSubjects will consume a ketogenic diet for 12 days. | Behavioural | 12 day ketogenic diet |
| 16 Hour FastSubjects will fast for 16 hours. | Behavioural | 16 hour fast |
Primary outcome
Changes in circulating plasma levels of key metabolic regulators
Time frame: 1 week
1 secondary outcome
A secondary outcome is change in energy expenditure with diet-induced ketosis.
Time frame: 1 week
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.
Eleftheria Maratos Flier, 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 Dietary manipulation ketogenic diet, Dietary Manipulation - 12 day ketogenic diet and 16 Hour Fast in people with Metabolic Regulation and 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 6 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?
Changes in circulating plasma levels of key metabolic regulators (time frame: 1 week). 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.