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Clinical Trials/NCT00476125
NCT00476125
Completed
Not Applicable

Effects of Dietary Manipulation on Metabolism in Healthy Adults

Beth Israel Deaconess Medical Center1 site in 1 country20 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Regulation
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Changes in circulating plasma levels of key metabolic regulators
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
August 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jody Dushay

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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

Outcomes

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.(1 week)

Study Sites (1)

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