Effects of Dietary Manipulation on Metabolism in Healthy Adults

Fasting Clinical Trial

Official title:

Effects of Dietary Manipulation on Metabolism in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476125
• Other study ID #: 2007P000017
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: August 2023

Study information

• Verified date: August 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasting
• Ketogenic Diet
• Metabolic Regulation

Intervention

Behavioral:
• Dietary manipulation ketogenic diet
Subjects will consume a ketogenic diet for 3 days.
• Dietary Manipulation - 12 day ketogenic diet
Subjects will consume a ketogenic diet for 12 days.
• 16 Hour Fast
Subjects will fast for 16 hours.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in circulating plasma levels of key metabolic regulators		1 week
Secondary	A secondary outcome is change in energy expenditure with diet-induced ketosis.		1 week