Effects of Dietary Manipulation on Metabolism in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Dietary Manipulation on Metabolism in Healthy Adults

Conditions
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Metabolic Regulation, Fasting, Ketogenic Diet

Intervention / Treatment
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* Behavioral: Dietary manipulation ketogenic diet
* Behavioral: Dietary Manipulation - 12 day ketogenic diet
* Behavioral: 16 Hour Fast


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Men and women ages 18-60 BMI 21-28 kg/m2 Stable weight (variation < 3 kg within 6 months of screening visit) Ability to give informed consent Ability to follow verbal and written instructions in English Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) 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 History of pancreatitis Depression or psychosis Renal insufficiency (creatinine clearance < 50 ml/min) Transaminases > 2x above the normal range Known liver disease Pregnancy within 6 months of the screening visit Lactation Failure to use medically approved contraceptive methods History of an eating disorder (anorexia, bulimia or laxative abuse) History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) New diagnosis of hypo or hyperthyroidism within 1 year of screening visit History of alcohol abuse within the past 5 years Seizure disorder Gout Kidney stones

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 day ketogenic diet<br> | Behavioral: Dietary manipulation ketogenic diet<br>* Subjects will consume a ketogenic diet for 3 days.<br>|
| Experimental: 12 day ketogenic diet<br> | Behavioral: Dietary Manipulation - 12 day ketogenic diet<br>* Subjects will consume a ketogenic diet for 12 days.<br>|
| Experimental: 16 hour fast<br> | Behavioral: 16 Hour Fast<br>* Subjects will fast for 16 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in circulating plasma levels of key metabolic regulators |  | 1 week | 

Secondary Outcome Measures

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