Effects of Dietary Manipulation on Metabolism in Healthy Adults
NCT ID: NCT00476125
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-03-31
2023-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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3 day ketogenic diet
Dietary manipulation ketogenic diet
Subjects will consume a ketogenic diet for 3 days.
12 day ketogenic diet
Dietary Manipulation - 12 day ketogenic diet
Subjects will consume a ketogenic diet for 12 days.
16 hour fast
16 Hour Fast
Subjects will fast for 16 hours.
Interventions
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Dietary manipulation ketogenic diet
Subjects will consume a ketogenic diet for 3 days.
Dietary Manipulation - 12 day ketogenic diet
Subjects will consume a ketogenic diet for 12 days.
16 Hour Fast
Subjects will fast for 16 hours.
Eligibility Criteria
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Inclusion Criteria
2. BMI 21-28 kg/m2
3. Stable weight (variation \< 3 kg within 6 months of screening visit)
4. Ability to give informed consent
5. Ability to follow verbal and written instructions in English
6. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
Exclusion Criteria
2. Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
3. Uncontrolled hypertension (BP \> 150/90 mmHg on or off antihypertensive medication)
4. Dyslipidemia
5. Tobacco, marijuana or intravenous drug use
6. Shift workers (night shift or alternating day/night shifts)
7. Recent weight loss (\> 3 kg within 6 months of the screening visit)
8. Gastroparesis
9. Inflammatory bowel disease
10. Malignancy treated with chemotherapy within the past 3 years
11. History of pancreatitis
12. Depression or psychosis
13. Renal insufficiency (creatinine clearance \< 50 ml/min)
14. Transaminases \> 2x above the normal range
15. Known liver disease
16. Pregnancy within 6 months of the screening visit
17. Lactation
18. Failure to use medically approved contraceptive methods
19. History of an eating disorder (anorexia, bulimia or laxative abuse)
20. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
21. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
22. History of alcohol abuse within the past 5 years
23. Seizure disorder
24. Gout
25. Kidney stones
18 Years
60 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Jody Dushay
Principal Investigator
Principal Investigators
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Eleftheria Maratos Flier, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2007P000017
Identifier Type: -
Identifier Source: org_study_id
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