Impact of Erythropoietin on Hematological Adaptations and Physical Performance

Completed · Phase 4

Conditions studied: Exercise-Induced Anemia, Physical Performance

In brief

Negative hematological adaptations due to prolonged periods of strenuous physical activity may, in part, contribute to declines in physical performance during military operations. Exogenous erythropoietin (EPO) is a potential intervention that may be used to maintain hemoglobin (hgb), hematocrit (Hct), and physical performance during periods of high physical activity. The objective of the current study is to determine the ability of EPO to maintain hgb, Hct, and physical performance compared to baseline measures. Additionally, EPO may result in non-hematological adaptations which increase mitochondria biogenesis and alter substrate oxidation. As such, this study will also assess the influence of EPO on whole-body and skeletal muscle substrate oxidation. Eight healthy physically active individuals will be recruited to participate in this longitudinal trial. After exercise practice sessions, volunteers will complete baseline physical performance (time trial) and substrate oxidation testing. Participants will then receive EPO injections 3 times per week for 4 weeks. Diet and exercise will be controlled during the injection period. Participants will undergo four weeks of an intense physical training exercise program. Every seventh day during the injection period a safety blood sample, assessing hematocrit, will be drawn, and participants will complete a 5 km time trial to determine the time course of changes in physical performance can be detected. After the 4 weeks of EPO injections volunteers will complete the same physical performance and substrate oxidation testing. Substrate oxidation will be assessed during 90-min steady-state load carriage (30% body mass) exercise on a treadmill at 55 ± 5% of VO2peak. 6-6-\[2H2\] glucose tracer technique and indirect calorimetry will be used measure substrate oxidation. Muscle biopsies will be performed to measure muscle glycogen, enzyme activity, and molecular markers of metabolism and inflammation before, and immediately and 3-hrs post exercise. Multiple blood samples will be collected throughout the study to determine alterations in hemoglobin, hematocrit, and markers of substrate metabolism, and inflammation. All study procedures will occur at USARIEM. The primary risks associated with this study include those associated with EPO injection, exercise, blood draws, and muscle biopsies.

Key facts

Study ID

NCT05078138

Run by

United States Army Research Institute of Environmental Medicine

People needed

8

Starts

2021-09-01

Expected to finish

2023-04-01

Last updated by the study team

2025-04-18

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women aged 18 - 39 years
• Weight stable (±5 lbs) for at least 2 months prior to the start of the study
• Body mass index (BMI) between 18.5-30 kg/m2
• Recreationally active (minimum 2-4 days per week aerobic and/or resistance exercise)
• Refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®, or any aspirin-containing product for 10 days before and at least 5 days AFTER each muscle biopsy. (*Tylenol® or acetaminophen is ok to use if needed for discomfort)
• Refrain from the use of alcohol and nicotine while on study diets
• Supervisor approval for federal civilian employees working within the US Army Natick Soldier Systems Center

You may not qualify if…

• Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, hypertension etc.)
• Personnel or family history of blood clots
• Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
• Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
• History of inflammatory bowel disease
• History of seizures
• Anemia (HCT < 38) and Sickle Cell Anemia/Trait
• Abnormal PT/PTT test or problems with blood clotting
• Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
• History of malignancy
• Use of oral contraceptives or hormone replacement therapy due to increased risk of clotting
• Musculoskeletal injuries that compromise the ability to exercise
• Blood donation within 8 weeks of beginning the study
• Are unwilling or unable to eat study diets and foods provided and/or follow exercise prescriptions
• Pregnancy, post-partum status, or breastfeeding

Where it is running

• US Army Research Institute of Environmental Medicine — Natick, Massachusetts, United States

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