Effects of Dietary Manipulation on Metabolism in Healthy Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00476125|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2007
Last Update Posted : July 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Regulation Fasting Ketogenic Diet||Behavioral: Dietary manipulation ketogenic diet Behavioral: Dietary Manipulation - 12 day ketogenic diet Behavioral: 16 Hour Fast||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Dietary Manipulation on Metabolism in Healthy Adults|
|Actual Study Start Date :||March 2008|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||December 2023|
|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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476125
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Eleftheria Maratos Flier, MD||Beth Israel Deaconess Medical Center|