Metabolism and Thyroid Hormone Changes During Exposure to Cold Temperatures
Public ClinicalTrials.gov record NCT00521729. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Thyroid Hormones Homeostasis and Energy Metabolism Changes During Exposure to Cold Temperature in Humans
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will examine how body metabolism adjusts to small changes in environmental temperature and how it may be related to weight loss. Healthy, non-obese individuals between 18 and 60 years of age may be eligible for this study. The study consists of one screening visit and one 5-day admission to the NIH Clinical Center for the following procedures: Diet: Participants follow a proscribed diet consisting of 50% carbohydrates, 20% protein and 30% fat. DEXA scan to measure body fat. Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body. Air displacement plethysmography (Bod-Pod) to study fat composition: Subjects sit in a small booth for 10 minutes wearing a swim suit and breathing normally through a tube. This test measures the person s weight and volume precisely. Metabolic room: Subjects stay 12 hours in a specialized room designed to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out. The room contains a private toilet and sink, treadmill, bed, desk, window, telephone and computer with television and internet access. While in this room, subjects undergo the following: * Continuous heart rate monitor: Subjects wear an EKG monitor to analyze heart rate variability. * Spontaneous movements: Subjects wear portable accelerometers at the hip and wrist to measure spontaneous physical movements. * Continuous temperature monitor: Subjects swallow a small capsule that transmits internal body temperature via miniature, wireless sensors. Adhesive patches placed on the skin monitor external body temperature. * Blood and urine collections: Subjects collect all of their urine during the 12 hours they are in the metabolic room. Blood samples are taken at specified intervals through a catheter that has been placed in a vein. * Microdialysis: A small needle is placed into fat tissue just under the skin on the abdomen. A solution containing a minimal amount of ethanol is infused and samples of fluid are collected every 20 minutes as it leaves the fat pad. This helps determine the metabolism level. This procedure starts 30 minutes before entering the metabolic room and continues until the subject leaves the room. Fat tissue biopsy: A small piece of fat tissue is withdrawn through a needle from under the skin on the abdomen. The sample is used to study fat tissue size and ability to store sugar.
Study identification
- NCT ID
- NCT00521729
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 23, 2007
- Primary completion
- Jan 11, 2015
- Completion
- Jun 25, 2018
- Last update posted
- Dec 15, 2019
2007 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00521729, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2019 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00521729 live on ClinicalTrials.gov.