Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
NCT07542873

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

Led by Pennington Biomedical Research Center · Updated on 2026-04-21

30

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

Sponsors

P

Pennington Biomedical Research Center

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obese with a BMI between 30-39.9 kg/m2
  • Born at altitudes below 2,100 meters (about 7,000 feet)
  • Currently living in Baton Rouge, Louisiana or nearby areas
  • Not taking medications that interfere with oxygen delivery or breathing for at least 4 weeks before and during the study
  • Willing to avoid smoking, vaping, chewing tobacco, and dietary supplements during the study
  • Willing to have a hypoxic tent set up at home and spend 8 hours per night in it for 8 weeks
Not Eligible

You will not qualify if you...

  • Living in or recently traveling to areas above 1,200 meters (about 4,000 feet) for 5 days or more within the last 2 months
  • Having cardiovascular, gastrointestinal, kidney, or other diseases that affect oxygen delivery or transport
  • Oxygen saturation below 95% while awake or below 88% for at least 10 minutes overnight in normal oxygen conditions
  • Having sleep apnea or other sleep disorders
  • History or diagnosis of high-altitude pulmonary or cerebral edema
  • Diagnosis or family history of sickle cell anemia or trait
  • Hematocrit levels below 42% for males or 36% for females
  • Hemoglobin levels below 13 g/dL for males or 12 g/dL for females
  • Donated blood within 8 weeks before starting the study
  • Current alcoholism, anabolic steroid use, or other substance abuse
  • Women who are pregnant, breastfeeding, planning pregnancy, or had irregular menstrual cycles in the past 6 months
  • Weight change greater than 10% in the past 6 months
  • Adults unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

R

Recruitment Core

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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