Effects of Dietary Manipulation on Metabolism in Healthy Adults
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|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||basic science|
Changes in circulating plasma levels of key metabolic regulators
time frame: 1 week
A secondary outcome is change in energy expenditure with diet-induced ketosis.
time frame: 1 week
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
|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.|
Call for more information