Defining the Functional Role of Iron in Aerobic Training and Physical Performance
NCT03002090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109
Last updated 2016-12-23
Summary
Iron deficiency is known to negatively impact physical performance, attention, and time spent doing physical activity. As a result, an iron deficient person must expend more energy to complete the same amount of work as someone who is healthy. Another interesting relationship has been observed between exercise training and iron status in that women who participate in exercise training often have higher rates of iron deficiency than sedentary women. ID is commonly treated using daily iron supplementation. However, it is currently unknown whether participating in regular exercise somehow impacts the effectiveness of iron supplementation. Iron deficient women who participate in exercise programs may potentially benefit less from iron supplementation than those who do not. Another common treatment for the symptoms of iron deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li (BZKL). While studies have shown that BZKL impacts expression of some iron-related proteins and increases endurance performance in rats, no studies have examined the efficacy of BZKL in improving iron markers or physical performance in humans. This study will compare the efficacy of BZKL in improving iron status and physical performance with that of ferrous sulfate supplementation. The Cornell research team will achieve these objectives in collaboration with colleagues at Kunming Medical University (KMU) in Kunming, China. A double-blind, randomized, placebo controlled study will be conducted by a Cornell graduate student at KMU. The subjects will be healthy women, age 18-26 years, attending KMU. Blood samples will be collected and analyzed for measures of iron).
Subjects will be randomly assigned to receive 50 mg of ferrous sulfate (10 mg of elemental iron), 6mg of BZKL, or an identical placebo pill twice daily for 8 weeks. Subjects will be further randomly sub-divided to receive aerobic exercise training or no training during the 8-week supplementation period. At weeks 4 and 8, subjects will perform the same series of tests as was performed at baseline. The investigators hypothesize that: 1. the women who train and received iron will have smaller improvements in iron status than those who do not train 2. The women who receive iron and train will have greater improvements in physical performance than those who train and do not receive iron, and 3. The women who receive BZKL will improve their iron status or physical performance more than those who receive placebo.
Conditions
- Iron Deficiency Without Anemia
Interventions
- DIETARY_SUPPLEMENT
-
Iron trained
1. Ferrous sulfate: 100 mg/day of FeSO4 dosed in 2 capsules taken individually by mouth with breakfast and dinner. Capsules were made with FeSO4 and dextrose. Analysis has shown that each capsule contains 11mg of elemental iron, which is expected to be absorbed at roughly 33% bioavailability. 2. Aerobic Training: 25 minutes/day, 5 days/week for 8 weeks working at an intensity between 75-85% of age-predicted maximum heart rate.
- DIETARY_SUPPLEMENT
-
Iron Untrained
1\. Ferrous sulfate: 100 mg/day of FeSO4 dosed in 2 capsules taken individually by mouth with breakfast and dinner. Capsules were made with FeSO4 and dextrose. Analysis has shown that each capsule contains 11mg of elemental iron, which is expected to be absorbed at roughly 33% bioavailability.
- DIETARY_SUPPLEMENT
-
BZKL Trained
1. BaZhen KeLi capsules: Traditional Chinese herbal supplement composed of: Radix Paeoniae Alba (White peony root), Rhizoma Atractylodis (Atractylodes), Rhizoma Chuanxiong (Chuanxiong), Radix Angelicae Sinensis (Angelica), Radix Codonopsis Pilosula (Codonopsis), Poria cocos (Poria), licorice, and Rehmannia glutinosa Each pill contained 5g of licorice and 10g of all other ingredients. Dosed in 2 capsules taken individually by mouth with breakfast and dinner. Analysis has shown that each capsule contained 0.5mg of elemental iron. 2. Aerobic Training: 25 minutes/day, 5 days/week for 8 weeks working at an intensity between 75-85% of age-predicted maximum heart rate.
- DIETARY_SUPPLEMENT
-
BZKL Untrained
1\. BaZhen KeLi capsules: Traditional Chinese herbal supplement composed of: Radix Paeoniae Alba (White peony root), Rhizoma Atractylodis (Atractylodes), Rhizoma Chuanxiong (Chuanxiong), Radix Angelicae Sinensis (Angelica), Radix Codonopsis Pilosula (Codonopsis), Poria cocos (Poria), licorice, and Rehmannia glutinosa Each pill contained 5g of licorice and 10g of all other ingredients. Dosed in 2 capsules taken individually by mouth with breakfast and dinner. Analysis has shown that each capsule contained 0.5mg of elemental iron.
- DIETARY_SUPPLEMENT
-
Placebo Trained
1\. Aerobic Training: 25 minutes/day, 5 days/week for 8 weeks working at an intensity between 75-85% of age-predicted maximum heart rate.
- DIETARY_SUPPLEMENT
-
Placebo Untrained
No intervention
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Jere Haas, PhD · Cornell University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 26 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- China
Study Locations
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