Iron Absorption in The Low Oxygen Exposure and Weight Status (LOWS) Study

ConditionObesity (Disorder)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22-65

SponsorPennington Biomedical Research Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Normobaric hypoxia (NH)
Other intervention
Low oxygen exposure to mimic \~8500 feet elevation (experimental)
Normobaric normoxia (NN)
Other intervention
Normal oxygen exposure to mimic sea level conditions (sham comparator).

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Normobaric hypoxia (NH)Experimental treatment 1 intervention

Group B: Normobaric normoxia (NN)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in iron absorption

Fractional iron absorption will be measured during the baseline weight maintenance phase (day -7) and at the end of the study (day 42). Change in fractional iron absorption will be calculated as: fractional iron absorption on day 42 - fractional iron absorption on day -7.

Time frame

7 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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