Status:
WITHDRAWN
Daily Low Oxygen Exposure and Weight Status
Lead Sponsor:
Florida State University
Conditions:
Overweight and Obesity
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
The objective of this single-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of ener...
Detailed Description
The current research study will evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calor...
Eligibility Criteria
Inclusion
- Men and women aged 20 - 50 years
- Overweight or obese (BMI between 27.5-34.9 kg/m2)
- Born at altitudes less than 2,100 meters (\~7,000 feet)
- Currently residing in Tallahassee, Florida, or the surrounding area
- Not taking any medication(s) that interfere with metabolism or oxygen delivery/transport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers, and/or any medication that depresses ventilation, diuretics, alpha, and beta-blockers).
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study
- Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks
- Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.
Exclusion
- Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders, and any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Evidence of apnea or other sleeping disorders
- Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
- Diagnosis or family history of sickle cell anemia/trait
- Hematocrit \<42% for males, \<36% for females
- Hemoglobin \<13 g/dL for males, \<12 g/dL for females
- Blood donation within 8 weeks of beginning the study
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Allergies or intolerance to foods included in the standardized and ad libitum meal tests (e.g., lactose intolerance/milk allergy)
- Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 mo.
- Weight gain or loss \> 10% of body weight during the past 6 months
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04801810
Start Date
May 1 2022
End Date
May 1 2023
Last Update
April 1 2022
Active Locations (1)
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1
Florida State University
Tallahassee, Florida, United States, 32306