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NCT01967563 · ClinicalTrials.gov registry record
Study of the Effect of a Very-Low-Carbohydrate Diet on Energy Expenditure
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Terminated
- Registry status
- 5
- Enrollment target
NCT01967563: Clinical Trial study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01967563 is a clinical trial that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01967563 was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- TERMINATED
- Registry status
- 5 participants
- Enrollment target
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-12-03 |
| Est. Completion | 2015-02-23 |
Why NCT01967563 stopped before completion
NCT01967563 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01967563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01967563 about?
NCT01967563 is a clinical study titled "Study of the Effect of a Very-Low-Carbohydrate Diet on Energy Expenditure". 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 wa...
What is the current status of trial NCT01967563?
This trial is currently terminated. The enrollment target is 5 participants. The study started on 2013-12-03. Estimated completion is 2015-02-23.
Who is sponsoring clinical trial NCT01967563?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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