Effects of Dietary Manipulation on Metabolism in Healthy Adults
1 other identifier
interventional
20
1 country
1
Brief 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 diet-induced ketosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedAugust 14, 2023
August 1, 2023
15.4 years
May 17, 2007
August 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in circulating plasma levels of key metabolic regulators
1 week
Secondary Outcomes (1)
A secondary outcome is change in energy expenditure with diet-induced ketosis.
1 week
Study Arms (3)
3 day ketogenic diet
EXPERIMENTAL12 day ketogenic diet
EXPERIMENTAL16 hour fast
EXPERIMENTALInterventions
Subjects will consume a ketogenic diet for 3 days.
Subjects will consume a ketogenic diet for 12 days.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleftheria Maratos Flier, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
March 1, 2008
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08