Iron Absorption in The Low Oxygen Exposure and Weight Status (LOWS) Study
Recruiting · NCT07542873 · Interventional (participants receive a specific treatment) · Lead sponsor: Pennington Biomedical Research Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Declines in iron status are common in those with obesity and may be due to obesity-related chronic inflammation; however, the effects of reducing inflammation following diet-induced weight loss on iron metabolism are poorly understood. Low environmental oxygen exposure increases dietary iron absorption and availability to supply iron for erythropoiesis but has not yet been tested in the context of weight loss. This study is designed to investigate diet-induced weight loss (inflammation reduction) and overnight low oxygen exposure (erythropoiesis stimulating agent) as strategies to improve dietary iron absorption in obesity.
Who can take part
Inclusion criteria
- Obese (BMI between 30-39.9 kg/m2)
- Born at altitudes below 2,100 meters (\~7,000 feet)
- Currently residing in Baton Rouge, Louisiana or surrounding area
- Not taking any medication(s) that interfere with 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
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 2 months
- Cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with oxygen delivery/transport (e.g., kidney disease, cardiovascular disease, etc.)
- Oxygen saturation \< 95% while awake or oxygen saturation dips below 88% for a total of ≥ 10 min overnight in normoxic conditions
- 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
- 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
Where it is running
1 location listed across 1 US state.
- Pennington Biomedical Research Center - Baton Rouge, Louisiana, United States