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

NCT01967563 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2025-04-22

No results posted yet for this study

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.

Conditions

  • Obesity
  • Appetite
  • Healthy Volunteers

Sponsors & Collaborators

  • Pennington Biological Research Center

    collaborator UNKNOWN

  • Translational Research Institute for Metabolism and Diabetes

    collaborator UNKNOWN

  • Columbia University, New York, NY

    collaborator UNKNOWN

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

    lead NIH

Principal Investigators

  • Kevin Hall, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-03
Primary Completion
2015-02-23
Completion
2015-02-23

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967563 on ClinicalTrials.gov