Effects of Dietary Manipulation on Metabolism in Healthy Adults

Not Applicable

Completed

• Conditions: Ketogenic Diet; Metabolic Regulation; Fasting
• Interventions: Behavioral: Dietary Manipulation - 12 day ketogenic diet; Behavioral: Dietary manipulation ketogenic diet; Behavioral: 16 Hour Fast

• Registration Number: NCT00476125
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Study Start: 2008-03
• Status Verified: 2023-08
• Primary Completion: 2023-08
• Study Completion: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
12 day ketogenic diet	Dietary Manipulation - 12 day ketogenic diet	-
3 day ketogenic diet	Dietary manipulation ketogenic diet	-
16 hour fast	16 Hour Fast	-

Primary Outcome Measures

Name	Time	Method
Changes in circulating plasma levels of key metabolic regulators	1 week

Secondary Outcome Measures

Name	Time	Method
A secondary outcome is change in energy expenditure with diet-induced ketosis.	1 week

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States