ClinicalTrials.gg
CompletedNCT07542873LOWS-IRONUpdated Oct 5, 2026

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

An interventional study of Normobaric hypoxia (NH) and Normobaric normoxia (NN) in Obesity (Disorder), sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2025, registered Apr 2026).
Updated Oct 5, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
22 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 67 studies in Obesity by Pennington Biomedical Research Center — 9 open to participants now, 13 under way, none of them phase 3. Obesity · Pennington Biomedical Research Center.

Enrollment
35th of 45
16 · median 42
Started
2025
with 4 others
No phase
36 of 67
5 open now
Registered
65th of 67
by date

Among the 67 studies in Obesity by Pennington Biomedical Research Center, this one is the 35th largest by enrollment of the 45 interventional ones that give a count, is one of 5 that started in 2025, is one of 36 with no phase, and was the 65th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

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Open to participants now

9 of the 67 studies in Obesity by Pennington Biomedical Research Center are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

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Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 22 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

Those with obesity are at increased risk for iron deficiency, which can worsen obesity-related comorbidities and add considerably to national health-care budgets. Declines in iron status in those with obesity may be due to adiposity-related inflammation. Adipokines, such as interleukin 6, increase hepcidin, an iron regulatory hormone secreted by the liver that functions to reduce iron absorption and iron availability. Elevated hepcidin and reduced dietary iron absorption may explain why those with obesity are more susceptible to iron deficiency and more resistant to treatment with iron supplements. However, the effects of reducing inflammation on iron absorption in those with obesity are poorly understood. In addition, low environmental oxygen exposure may be an alternative to optimize iron metabolism in obesity since hypoxia stimulates the synthesis of erythropoietin, which strongly suppresses hepcidin and increases iron absorption. The proposed study aims to capitalize on the ongoing Low Oxygen and Weight Status (LOWS) randomized, double-blind, parallel-arm, controlled-feeding trial (R01DK127162; Berryman) to understand the mechanism by which obesity increases risk for iron deficiency and potential countermeasures. In LOWS, adults with obesity are randomized to 8 weeks of controlled-feeding energy restriction (-500 kcal/day) plus intermittent exposure to normobaric hypoxia (8 h/night, 15% FiO2) or normoxia (8 h/night, 21% FiO2) using a commercially available, in-home tent system. This study aims at assessing dietary iron absorption at baseline and following 8 weeks of energy restriction in normoxia or intermittent hypoxia. Results of this project will serve as a foundation to the development of interventions to prevent and treat declines in iron status in obesity.

03

Conditions studied

  • Obesity (Disorder)

Keywords

  • Body weight
  • Normobaric hypoxia
  • Negative energy balance
  • Energy intake
  • Energy expenditure
  • Iron absorption
  • Iron metabolism
04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Obese ( 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

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
  • \<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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Normobaric hypoxia (NH)

    8 weeks of overnight exposure (8 hrs/night) to NH conditions (\~15% oxygen; achieved with nitrogen dilution, equivalent to \~8500 feet elevation) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).

    Other: Normobaric hypoxia (NH)

  • Sham comparator
    Normobaric normoxia (NN)

    8 weeks of overnight exposure (8 hrs/night) to NN conditions (\~21% oxygen; sea level) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).

    Other: Normobaric normoxia (NN)

Interventions

  • OtherNormobaric hypoxia (NH)

    Low oxygen exposure to mimic \~8500 feet elevation (experimental)

  • OtherNormobaric normoxia (NN)

    Normal oxygen exposure to mimic sea level conditions (sham comparator).

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

References and documents

Publications

  • Riley TM, Weschenfelder C, Ravussin E, Rood JC, Greenway F, Taff S, Hickner RC, Cao H, Sutin AR, Todd G, Hennigar SR, Berryman CE. Effects of daily low oxygen exposure on weight status, body composition, and metabolic health in adults with obesity: protocol for a randomized, double-blind, controlled-feeding study. Contemp Clin Trials. 2026 Jan;160:108167. doi: 10.1016/j.cct.2025.108167. Epub 2025 Nov 26. PubMed 41314599 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Sep 2026, 16 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 16 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: primary completion Jun 2026 → Sep 2026 and completion Jun 2026 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 21, 2026
StartActual
Apr 21, 2025
Primary completionActual
Sep 1, 2026was Jun 2026
CompletionActual
Sep 1, 2026was Jun 2026
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 5, 2026
Primary completion
Jun 30, 2026→Sep 1, 2026 (actual)
Oct 5, 2026
Study completion
Jun 30, 2026→Sep 1, 2026 (actual)
Oct 5, 2026
Enrollment
30 (estimated)→16 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Recruiting→Completed
    Primary completion Jun 30, 2026→Sep 1, 2026 (now actual)
    Study completion Jun 30, 2026→Sep 1, 2026 (now actual)
    Enrollment 30 (estimated)→16 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07542873
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
Apr 21, 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026
Last update
Oct 5, 2026

Study contacts

Camila Weschenfelder, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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