Collegiate Athlete Study
Low Energy Availability, Iron Deficiency, Low Vitamin D, and Male and Female Athlete Triad Risk Among Black Collegiate Athletes - A Pilot Study
調査の概要
状態
詳細な説明
A quasi-experimental one group pre-test/post-test design will be utilized in the current investigation among collegiate cross-country and track and field athletes from a Historically Black College and University (HBCU). Members of the men's and women's varsity cross-country teams and track & field teams at this HBCU will be asked to participate in this IRB approved study. Participants who decide to enroll in the study will be asked to sign consent forms.
A 4-question Male Athlete Triad Cumulative Risk Assessment or the 6-question Female Athlete Triad Cumulative Risk Assessment will be completed by each participant.
Participants will have Complete Blood Counts (CBCs), ferritin levels, and Vitamin D levels assessed via blood drawn by phlebotomists. Specimens will be sent to Quest Labs for analysis and results will be uploaded into a secure database.
Athletes will be asked to complete the modified Nutritional/Exercise Survey, which will ask information regarding their daily energy intake, exercise energy expenditure, consumption of macronutrients and food groups, as well as eating patterns, dietary restrictions, and supplement use. The survey will be administered and stored by Qualtrics, a password-protected encrypted platform.
In addition to questions about food intake, each athlete will be asked about the amount and intensity of all aerobic and anerobic exercise they do weekly - including resistance training. Each type of activity will be assigned a specific metabolic equivalent (MET) value. The total MET value per athlete will be based on an athlete's body weight and their total number of exercise hours according to the American College of Sports Medicine's Compendium of Physical Activity.
Participants will meet with a dietitian to further assess their dietary intake, complete a 24-hour dietary recall, and evaluate the athletes' nutrition habits. Information from the dietary consultation, 24-hour recall, and nutrition/exercise survey will be combined to calculate an athlete's risk of energy deficiency.
Athletes will also complete a DEXA scan and undergo an indirect calorimetry assessment. Information from these tests, including the athletes' fat mass, muscle mass, full body Z-score and lumbar spine Z-score (as measures of bone density), and resting metabolic rate will be uploaded into a secure database.
Participants will be given "Calorify Pro Kits" which require them to drink a small sample of doubly labeled water (DLW) then collect 3 urine samples over the course of 1 week, daily weights for 3 weeks, and food intake data. Data from this DLW process, which is currently the gold standard for energy expenditure, will be used to objectively measure energy availability in addition to information collected from dietitians and survey results. All data will be uploaded into a secure database.
Participants will be asked to wear Oura rings on their nondominant hands for 6 weeks initially. Once they return from winter break to start their outdoor season they will be asked to wear the Oura ring for an additional 12 weeks. The Oura rings will track their active vs total caloric expenditure as well as provide ancillary data regarding their sleep effectiveness, basal body temperature, and heart rate.
Once all data have been collected, athletes with iron deficiency or iron deficiency anemia or suboptimal Vitamin D will be notified and given supplements to take daily for 3 months. They will also complete surveys regarding their energy level and quality of life. After 3 months of taking the supplements, the participants will have their blood levels and bone mass reassessed.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30310
- Morehouse School of Medicine
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Members of an HBCU cross-country or track & field team
- 18 years of age or older
- Self-identification as Black or African American
Exclusion Criteria:
-Pregnancy
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Determining Nutritional Status and Treating As Needed
Determining energy availability, nutritional status and bone density, then providing iron and vitamin D supplementation as needed.
|
Participants found to be low in Iron and/or Vitamin D will be given supplementation. Athletes who are classified as having Iron Deficiency will take iron bisglycinate 25mg oral supplements daily for 3 months. Those who are classified as having Iron Deficiency Anemia will take iron bisglycinate 50mg daily for 3 months. Those classified as having suboptimal Vitamin D or Vitamin D insufficiency will take 1 tab of Vitamin D 5,000 IU supplements daily for 3 months. Those who have Vitamin D deficiency will take 2 tabs of Vitamin D 5,000 IU supplements daily for 3 months. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Black Collegiate Athletes with Low Energy Availability
時間枠：9 months
|
Females with an energy availability score over 45kcal/kg/FFM will be classified as having normal energy availability, those with an energy availability score of 30 to 45 kcal/kg/FFM will be classified as having subclinical low energy availability, and those with an energy availability score of less than 30 kcal/kg/FFM will be classified as having clinical low energy availability. Males with an energy availability score over 30kcal/kg/FFM will be classified as having normal energy availability, those with an energy availability score of 15 to 30 kcal/kg/FFM will be classified as having subclinical low energy availability, and those with an energy availability score of less than 15 kcal/kg/FFM will be classified as having clinical low energy availability. |
9 months
|
|
Proportion of Black Collegiate Athletes with Low Vitamin D at Baseline and Following Supplement Intervention Protocol
時間枠：9 months
|
Athletes will have Vitamin D levels assessed via blood draws.
Those with a Vitamin D level less than 20 ng/mL will be categorized as having Vitamin D deficiency.
Those with a Vitamin D level between 20 and 30 ng/mL will be categorized as having Vitamin D insufficiency.
Those with a Vitamin D between 30 and 50 ng/mL will be categorized as having suboptimal Vitamin D. Those with a Vitamin D level above 50 ng/mL will be categorized as having optimal Vitamin D.
|
9 months
|
|
Proportions of Black Collegiate Athletes with Iron Deficiency and Iron Deficiency Anemia at Baseline and Following Supplement Intervention Protocol
時間枠：9 months
|
Athletes will be identified as having iron deficiency (ID) or iron deficiency anemia (IDA) based on lab results.
Any male or female athlete with a ferritin level below 35 ng/mL will be classified as having ID.
Any female athlete with a ferritin level below 12 ng/mL and a hemoglobin below 12.0 g/dL will be classified as having IDA.
Any male athlete with a ferritin below 35 ng/mL and a hemoglobin below 13.0 g/dL will be classified as having IDA.
|
9 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Black Collegiate Athletes with Low Bone Density at Baseline and Following Supplement Intervention Protocol
時間枠：9 months
|
Athletes will also complete a Dual-energy X-ray Absorptiometry (DXA) scan.
Information from this scan, including the athletes' fat Mass, muscle mass, full body Z-score, and lumbar spine Z-score (as a measure of bone density) will be recorded.
A Z-score is a measure of bone mineral density (BMD) that compares an individuals BMD to a reference population of other people that are their same age, sex, and ethnicity.
It is expressed as a number of standard deviations from the mean.
A Z-score of 0 means the BMD is exactly average for peers.
Positive values (a score above 0) indicate higher-than-average BMD.
Negative values (a score below 0) indicate lower-than-average BMD.
Any athlete with a Z-score less than -1.0 will be classified as having low BMD.
|
9 months
|
|
Proportion of Black Collegiate Athletes with Food Insecurity
時間枠：9 months
|
The U.S. Household Food Security Survey Module: Six-item short 101 form, from the United States Department of Agriculture (USDA) will be used.
Athletes with a score of 0-1 will be classified as food secure; those with scores from 2-6 will be classified as food insecure.
|
9 months
|
|
Proportion of Black Collegiate Athletes Reporting Dietary Restrictions, Skipping Meals, and Low Dietary Intake of Iron and Vitamin D
時間枠：9 months
|
Participants will complete the Athlete Nutrition Screening Survey (ANSS) to evaluate dietary behaviors, exercise energy expenditure, energy and macronutrient intake, food group intake, and dietary supplement use over the previous four weeks.
They will also meet one-on-one with a registered dietitian to complete a 24-hour dietary recall.
|
9 months
|
|
Quantity of Sleep among Black Collegiate Athletes
時間枠：9 months
|
Participants will wear the Oura ring while sleeping, and it will track how many hours and minutes they are in bed.
It will also track how many hours and minutes they are asleep.
|
9 months
|
|
Quality of Sleep Among Black Collegiate Athletes
時間枠：9 months
|
Athletes will wear the Oura ring as they sleep.
It will determine the quality of their sleep by automatically calculating a sleep score which will range from 0 to 100.
The higher the score the better.
A score of 85 or higher is optimal, 70 to 84 is good, and <70 needs improvement.
Oura Ring does not disclose the exact calculation for the sleep score.
However they do state that the sleep score will be based off of 7 different factors: 1) Total Sleep: Did the athlete get enough sleep, 2) Efficiency: How much of the athlete's time in bed did they actually spend sleeping, 3) Restfulness: Did the athlete toss and turn during sleep, 4) Rapid Eye Movement (REM) Sleep: Did the athlete get enough REM sleep, 5) Deep Sleep: Did the athlete get enough deep sleep, 6) Latency: How quickly did the athlete fall asleep, and 7) Timing: When is the athlete getting to sleep and are they going to bed according to their body's natural circadian rhythm.
|
9 months
|
協力者と研究者
捜査官
- 主任研究者：Altelisha Taylor, MD, MPH、Morehouse School of Medicine
出版物と役立つリンク
一般刊行物
- De Souza MJ, Nattiv A, Joy E, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G; Female Athlete Triad Coalition; American College of Sports Medicine; American Medical Society for Sports Medicine; American Bone Health Alliance. 2014 Female Athlete Triad Coalition consensus statement on treatment and return to play of the female athlete triad: 1st International Conference held in San Francisco, CA, May 2012, and 2nd International Conference held in Indianapolis, IN, May 2013. Clin J Sport Med. 2014 Mar;24(2):96-119. doi: 10.1097/JSM.0000000000000085.
- Heikura IA, Uusitalo ALT, Stellingwerff T, Bergland D, Mero AA, Burke LM. Low Energy Availability Is Difficult to Assess but Outcomes Have Large Impact on Bone Injury Rates in Elite Distance Athletes. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):403-411. doi: 10.1123/ijsnem.2017-0313. Epub 2018 Jun 12.
- Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
- Nattiv A, De Souza MJ, Koltun KJ, Misra M, Kussman A, Williams NI, Barrack MT, Kraus E, Joy E, Fredericson M. The Male Athlete Triad-A Consensus Statement From the Female and Male Athlete Triad Coalition Part 1: Definition and Scientific Basis. Clin J Sport Med. 2021 Jul 1;31(4):335-348. doi: 10.1097/JSM.0000000000000946.
- Barrack MT, Gray VB, Olson C, Richard C, West J. Comparative analysis between a brief nutrition screening survey and validated food frequency questionnaire among physically active college students. J Am Coll Health. 2023 Dec;71(9):2697-2704. doi: 10.1080/07448481.2021.1987248. Epub 2021 Nov 17.
- Edama M, Inaba H, Hoshino F, Natsui S, Maruyama S, Omori G. The relationship between the female athlete triad and injury rates in collegiate female athletes. PeerJ. 2021 Apr 6;9:e11092. doi: 10.7717/peerj.11092. eCollection 2021.
- Melanson EL, Swibas T, Kohrt WM, Catenacci VA, Creasy SA, Plasqui G, Wouters L, Speakman JR, Berman ESF. Validation of the doubly labeled water method using off-axis integrated cavity output spectroscopy and isotope ratio mass spectrometry. Am J Physiol Endocrinol Metab. 2018 Feb 1;314(2):E124-E130. doi: 10.1152/ajpendo.00241.2017. Epub 2017 Oct 3.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2177489
- 5R25MD007589-17 (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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。