低酸素曝露と体重状態における鉄吸収に関する研究（LOWS研究） (LOWS-IRON)
肥満におけるエネルギー制限と間欠性低酸素が鉄吸収に及ぼす影響
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Louisiana
-
Baton Rouge、Louisiana、アメリカ、70808
- Pennington Biomedical Research Center
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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). |
Low oxygen exposure to mimic ~8500 feet elevation (experimental) |
|
偽コンパレータ：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). |
Normal oxygen exposure to mimic sea level conditions (sham comparator). |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in iron absorption
時間枠：7 weeks
|
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. |
7 weeks
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Camila Weschenfelder, PhD、Pennington Biomedical Research Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 2022-046-PBRC
- U24DK132740 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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