Effects of Dietary Manipulation on Metabolism in Healthy Adults

August 9, 2023 updated by: Jody Dushay, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in circulating plasma levels of key metabolic regulators
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
A secondary outcome is change in energy expenditure with diet-induced ketosis.
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Eleftheria Maratos Flier, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

May 17, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimated)

May 21, 2007

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2007P000017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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