Heart Rate Variability Clinical Trial
Official title:
Effects of an Overnight, 8-hour Low Oxygen Exposure on Resting Energy Expenditure and Appetite: a Pilot Study
Verified date | November 2021 |
Source | Florida State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) and another night in NN (control) conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to ~1000 feet elevation).
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2, 2021 |
Est. primary completion date | October 2, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: - Men and women aged 20 - 45 years - Body mass index between 18.5 - 24.5 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 four weeks before 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 spend two overnight visits on the Florida State University campus. Exclusion Criteria: - 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 two months - Metabolic or cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.) - Prior diagnosis of apnea or other sleeping disorders - Prior diagnosis of high-altitude pulmonary edema or high-altitude cerebral edema - Prior diagnosis of anemia or sickle cell anemia/trait - Present condition of alcoholism, anabolic steroid, or other substance abuse issues - Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past six months. - Allergies or intolerance to foods included in the standardized or ad libitum meal (e.g., lactose intolerance/milk allergy) |
Country | Name | City | State |
---|---|---|---|
United States | Florida State University | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resting metabolic rate (kcal/d) following exposure to NH or NN conditions | Resting metabolic rate will be accessed using indirect calorimetry (TrueOne 2400, Parvo Medics, Salt Lake City, UT) following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Objective appetite following exposure to NH or NN conditions | Objective appetite will be assessed by measuring total energy intake during an ad libitum buffet-style meal provided to participants following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Food preferences following exposure to NH or NN conditions | Food preferences will be assessed by measuring macronutrient intake during an ad libitum buffet-style meal provided to participants following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Fasting and postprandial hunger following exposure to NH or NN conditions | Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN. | Hunger will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure | |
Secondary | Fasting and postprandial satiety following exposure to NH or NN conditions | Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN. | Satiety will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure | |
Secondary | Fasting and postprandial prospective food consumption following exposure to NH or NN conditions | Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN. | Prospective food consumption will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure | |
Secondary | Fasting and postprandial subjective appetite following exposure to NH or NN conditions | Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN. | Subjective appetite will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure | |
Secondary | Energy intake following exposure to NH or NN conditions | Energy intake will be accessed using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to complete dietary records for 2 days following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Macronutrient intake following exposure to NH or NN conditions | Macronutrient intake will be accessed using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to complete dietary records for 2 days following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Heart rate variability following exposure to NH or NN conditions | Heart rate variability will be measured using a 3-lead electrocardiogram following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Prevalence of acute mountain sickness following exposure to NH or NN conditions | Prevalence of acute mountain sickness will be accessed using the Environmental Symptoms Questionnaire following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Severity of acute mountain sickness following exposure to NH or NN conditions | Severity of acute mountain sickness will be accessed using the Environmental Symptoms Questionnaire following 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Continuous oxygen saturation during exposure to NH or NN | Oxygen saturation will be measured continuously using a finger pulse oximeter (PalmSAT® 2500, Nonin Medical, Inc., Plymouth, MN) during 8 hours of overnight exposure to NH or NN. | 8 hours | |
Secondary | Sleep quality following exposure to NH or NN conditions | Sleep quality will be measured by the Pittsburgh Sleep Quality Index following 8 hours of overnight exposure to NH or NN. | 8 hours |
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