NCT07542873 Iron Absorption in The Low Oxygen Exposure and Weight Status (LOWS) Study
| NCT ID | NCT07542873 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Obesity (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-21 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Camila Weschenfelder, PhD
PRINCIPAL INVESTIGATOR
Pennington Biomedical Research Center
Frequently Asked Questions
Who can join the NCT07542873 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 65 Years, studying Obesity (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07542873 currently recruiting?
Yes, NCT07542873 is actively recruiting participants. Contact the research team at clinicaltrials@pbrc.edu for enrollment information.
Where is the NCT07542873 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT07542873 clinical trial?
NCT07542873 is sponsored by Pennington Biomedical Research Center. The principal investigator is Camila Weschenfelder, PhD at Pennington Biomedical Research Center. The trial plans to enroll 30 participants.
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