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Effects of Dietary Manipulation on Metabolism in Healthy Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00476125
First received: May 17, 2007
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Metabolic Regulation
Fasting
Ketogenic Diet
 Behavioral: Dietary manipulation ketogenic diet
Behavioral: Dietary Manipulation - 12 day ketogenic diet
Behavioral: 16 Hour Fast
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Dietary Manipulation on Metabolism in Healthy Adults

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Changes in circulating plasma levels of key metabolic regulators [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary outcome is change in energy expenditure with diet-induced ketosis. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: February 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 day ketogenic diet Behavioral: Dietary manipulation ketogenic diet
Subjects will consume a ketogenic diet for 3 days.
Experimental: 12 day ketogenic diet Behavioral: Dietary Manipulation - 12 day ketogenic diet
Subjects will consume a ketogenic diet for 12 days.
Experimental: 16 hour fast Behavioral: 16 Hour Fast
Subjects will fast for 16 hours.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476125

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Eleftheria Maratos Flier, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Eleftheria Maratos-Flier, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00476125     History of Changes
Other Study ID Numbers: 2007P-000017
Study First Received: May 17, 2007
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013