This trial is active, not recruiting.

Conditions metabolic regulation, fasting, ketogenic diet
Treatments dietary manipulation ketogenic diet, dietary manipulation - 12 day ketogenic diet, 16 hour fast
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Start date March 2008
End date November 2015
Trial size 20 participants
Trial identifier NCT00476125, 2007P-000017


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
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.

Primary Outcomes

Changes in circulating plasma levels of key metabolic regulators
time frame: 1 week

Secondary Outcomes

A secondary outcome is change in energy expenditure with diet-induced ketosis.
time frame: 1 week

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion criteria: 1. Men and women ages 18-60 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: 1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association 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

Additional Information

Official title Effects of Dietary Manipulation on Metabolism in Healthy Adults
Principal investigator Eleftheria Maratos Flier, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.