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Study of the Effect of a Very-Low-Carbohydrate Diet on Energy Expenditure

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ClinicalTrials.gov Identifier: NCT01967563
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Pennington Biological Research Center
Translational Research Institute for Metabolism and Diabetes
Columbia University, New York, NY
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date October 22, 2013
First Posted Date October 23, 2013
Last Update Posted Date April 29, 2020
Actual Study Start Date December 3, 2013
Actual Primary Completion Date February 23, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2020)
To determine 24hr energy expenditure, respiratory quotient, and sleeping energy expenditure following a 4- week eucaloric ketogenic diet as compared to 4 weeks of consuming an energybalanced standard diet. [ Time Frame: 1 year ]
the subjects will spend the 4th, 5th, 11th, 12th, 18th, 19th, 25th and 26th days of Stages 2 & 3 in the metabolic chamber to measure 24-hour energy expenditure and sleeping energy expenditure. The energy expenditure calculations will be corrected for urinary ketone excretion since approximately 0.33 L of O2 is consumed for every gram of ketone excreted in the urine.
Original Primary Outcome Measures
 (submitted: October 22, 2013)
determine 24hr energy expenditure, respiratory quotient, and sleeping energy expenditure following a 4-week eucaloric ketogenic diet as compared to 4 weeks of consuming an energy-balanced standard diet. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2020)
  • To investigate changes in body composition and appetitive behaviors such as hunger, satiety, food impulsivity, and food liking & wanting during a 4-week eucaloric ketogenic diet as compared to 4 weeks of consuming an energy balanced stan... [ Time Frame: 7 days(outpatient) plus 8 weeks( inpatient) ]
    hunger and satiety assessments will be completed multiple times each day, and ad libitum meal tests and appetitive computer tasks (delay discounting, liking & wanting, go/no-go, food choice) will be performed during the latter periods of Stages 2 & 3.
  • To determine body weight and body composition following a 4-week eucaloric ketogenic diet as compared to 4 weeks of consuming an energy-balanced standard diet. [ Time Frame: 7 days (outpatient) plus 8 weeks (inpatient) ]
    measurement of body composition by DXA, isotope dilution, and air-displacement plethysmography (BodPod) will be performed on the 15th and 28th days of Stages 2 & 3. Measurement of total body water by administering deuterium oxide will be performed on the 28th day of Stages 2 & 3. Body weight will be measured daily.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Effect of a Very-Low-Carbohydrate Diet on Energy Expenditure
Official Title Effect of a Eucaloric Ketogenic Diet on Energy Expenditure: A Pilot Study
Brief Summary

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.
Detailed Description

Popular weight loss strategies often prescribe targeted reduction of dietary carbohydrate or fat. Recent clinical trials in obese subjects have found that low-carbohydrate diets result in greater weight loss compared with low-fat diets on a time scale of months when diet adherence was likely the highest. One hypothesis regarding the mechanism of improved weight loss with low carbohydrate diets is that such diets significantly modify the body s hormonal milieu to influence metabolic regulation and energy expenditure. Low-carbohydrate diets may thereby offer a metabolic advantage over low fat diets. In addition, low-carbohydrate diets may also decrease hunger or increase satiety compared to low-fat diets.

Determining the mechanism whereby one diet leads to greater weight loss than another is hampered by the inability to accurately measure food intake or physical activity in an outpatient setting. Thus, an inpatient feeding study lasting many weeks is required to accurately measure energy balance differences between isocaloric diets that differ in macronutrient composition. In this pilot multicenter cross-over study in 16 overweight and class I obese men, we will measure changes in energy expenditure in response to 4 weeks of inpatient feeding of a eucaloric, very low carbohydrate, ketogenic diet (5% Carbohydrate, 15% Protein, 80% Fat) immediately following an inpatient period of at least 4 weeks of consuming an energy balanced standard American diet (50% Carbohydrate, 15 % Protein, 35% Fat).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population We will study the magnitude and variability of energy expenditure changes in response to a eucaloric ketogenic diet subsequent to a standard energy- and macronutrient-balanced diet in overweight and class I obese adult male volunteers
Condition
  • Obesity
  • Appetite
  • Healthy Volunteers
Intervention Not Provided
Study Groups/Cohorts overweight and class I obese adult male volunteers
Adult Male Subjects (18-50) will be recruited in order to determine the effects on energy expenditure of transitioning from an energyand macronutrient-balanced standard baseline diet (50% carbohydrate, 35% fat, 15% protein) to a eucaloric ketogenic diet (5% carbohydrate, 80% fat, 15% protein).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2015)
5
Original Estimated Enrollment
 (submitted: October 22, 2013)
100
Actual Study Completion Date February 23, 2015
Actual Primary Completion Date February 23, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01967563
Other Study ID Numbers 130212
13-DK-0212
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
  • Pennington Biological Research Center
  • Translational Research Institute for Metabolism and Diabetes
  • Columbia University, New York, NY
Investigators
Principal Investigator: Kevin Hall, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 24, 2020