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Protocol Details

Effect of a Eucaloric Ketogenic Diet on Energy Expenditure: A Pilot Study

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-DK-0212

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male
Min Age: 18
Max Age: 50

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Female;
Children

Special Instructions

Currently Not Provided

Keywords

Energy Expenditure;
Obesity;
Carbohydrate;
Fat;
Ketones

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Appetite;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney DiseasesPennington Biological Research CenterTranslational Research Institute for Metabolism and DiabetesColumbia University, New York, NY

Background:

- Popular weight loss plans often restrict carbohydrates or fat. Research shows that very-low-carbohydrate (ketogenic) diets lead to greater weight loss than low-fat diets. Researchers want to know if eating fewer carbohydrates changes the number of calories the body uses. They also want to know how a ketogenic diet affects hunger, hormones, and food preferences.

Objectives:

- To better understand how the body responds to different diets.

Eligibility:

- Men 18 to 50 years old who are healthy but overweight.

Design:

- Participants will have 3 screening visits:

1. Medical history, physical exam, blood test, and EKG. They will eat during the visit.

2. For the week before the visit, participants will wear physical activity monitors daily. They will record everything they eat and sample the special diet. At the visit, they will receive an EKG and heart rate test while biking for 30 minutes.

3. For the week before the visit, participants will wear the physical activity monitors. They will eat all their meals from the special diet that will be provided. At the visit, they will answer questions and bike for 60 minutes.

- After screening, for 1 week, participants will visit the clinic daily to receive that day s food. They will not eat or drink anything else except water.

- Then participants will stay at the clinic for 8 weeks. They cannot leave but can have visitors. Participants will wear physical activity monitors, bike daily, and follow different diets. Tests will be given daily, and may include weighing, X-rays, and blood and urine tests. They will spend several days in a monitored room to test oxygen and carbon dioxide.

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Eligibility

INCLUSION CRITERIA:

-Age 18-50 years, male

-Weight stable (< 5 % over past 6 months)

-Current stable weight no more than 8% below lifetime maximum weight

-Body mass index (BMI) greater than or equal to 25 kg/m(2) but less than 35 kg/m(2), with each study site recruiting an equal number of subjects from the overweight range of 25 kg/m(2) less than or equal to BMI < 30 kg/m(2) and from the class I obese range of 30 kg/m(2) less than or equal to BMI < 35 kg/m(2)

-Otherwise healthy, as determined by medical history and laboratory tests

-Able to complete daily bouts of stationary cycling at a moderate rate and intensity

-Written informed consent

-Willing to eat all the food provided in the study

-Willing to continue consistently their habitual caffeine intake

EXCLUSION CRITERIA:

-BMI < 25 kg/m(2) or greater than or equal to 35 kg/m(2)

-Blood pressure > 140/90 mm Hg

-Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)

-Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)

-Hematocrit < 40%

-Participating in a regular exercise program (> 2h/week of vigorous activity)

-Dietary carbohydrate less than 30% or greater than 65% of total calories as determined by food frequency questionnaire

-Caffeine consumption > 300 mg/day

-Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months

-Past or present history of eating disorder (including binge eating) or psychiatric disease, including claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry

-Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies)

-Volunteers unwilling or unable to give informed consent


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kevin Hall, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 12A
Room 4007
12 South Drive
Bethesda, Maryland 20892
(301) 402-8248
kevinh@niddk.nih.gov

Lilian V. Howard, C.R.N.P.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C434
10 CENTER DR
BETHESDA MD 20814
(301) 594-0298
lh357n@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01967563

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