Defining the Functional Role of Iron in Aerobic Training and Physical Performance

NCT03002090 | Completed

• 1 other identifier: IRB #: 1402004495
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

iron deficiency; anemia; exercise training; aerobic; performance; Chinese medicine; BaZhen KeLi

Outcome Measures

Primary Outcomes (5)

• Concentration of serum ferritin in µg/L

  Changes from week 0 to weeks 4 and 8 measured both within and between groups.

  Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

• Concentration of soluble transferrin receptor in mg/L

  Changes from week 0 to weeks 4 and 8 measured both within and between groups.

  Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

• Concentration of hemoglobin g/L

  Changes from week 0 to weeks 4 and 8 measured both within and between groups.

  Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

• Concentration of alpha-1-acid glycoprotein in g/L

  Changes from week 0 to weeks 4 and 8 measured both within and between groups.

  Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

• Concentration of C-reactive protein in mg/L

  Changes from week 0 to weeks 4 and 8 measured both within and between groups.

  Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

Secondary Outcomes (2)

• Human performance as assessed by maximal capacity for oxygen uptake (mL/min/kg body weight)

  Change from weeks 0 to 8. Change from weeks 0 to 4.

• Human performance as assessed by energetic efficiency (in %)

  Change from weeks 0 to 8. Change from weeks 0 to 4.

Study Arms (6)

Iron trained

EXPERIMENTAL

Dietary Supplement: Iron trained

Iron Untrained

EXPERIMENTAL

Dietary Supplement: Iron Untrained

BZKL Trained

EXPERIMENTAL

Dietary Supplement: BZKL Trained

BZKL Untrained

EXPERIMENTAL

Dietary Supplement: BZKL Untrained

Placebo Trained

EXPERIMENTAL

Dietary Supplement: Placebo Trained

Placebo Untrained

PLACEBO COMPARATOR

Dietary Supplement: Placebo Untrained

Interventions

Iron trained DIETARY_SUPPLEMENT

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.

Iron trained

Iron Untrained DIETARY_SUPPLEMENT

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.

Iron Untrained

BZKL Trained DIETARY_SUPPLEMENT

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.

BZKL Trained

BZKL Untrained DIETARY_SUPPLEMENT

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.

BZKL Untrained

Placebo Trained DIETARY_SUPPLEMENT

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.

Placebo Trained

Placebo Untrained DIETARY_SUPPLEMENT

No intervention

Placebo Untrained

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-26
• Must be able to complete exercise on a stationary bicycle
• Clinical diagnosis of iron depletion without severe anemia (sFer\< 25µg/L, Hb\>110g/L)
• Willing to comply with the 8-week supplementation and if assigned, training program

You may not qualify if:

• age less than 18
• severe anemia (Hb\<90g/L in blood analyses)
• current pregnancy or pregnancy within the previous year
• recent infectious illness or fever
• current inflammation or chronic inflammatory diseases (AGP \> 1.0 g/L in blood analyses)
• hemolytic anemia
• chronic respiratory disease
• musculoskeletal problems
• history of eating disorders
• smoking, BMI \< 18 or \>24 kg/m2
• consumption of medications that may affect dietary iron intake or absorption or that have anticoagulant properties
• participation in varsity sports team

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Kunming Medical University, Department of Nursing,

Longcheng, Yunnan, China

Location

Related Publications (2)

• Pompano LM, Haas JD. Increasing Iron Status through Dietary Supplementation in Iron-Depleted, Sedentary Women Increases Endurance Performance at Both Near-Maximal and Submaximal Exercise Intensities. J Nutr. 2019 Feb 1;149(2):231-239. doi: 10.1093/jn/nxy271.

  PMID: 30649365 DERIVED

• Pompano LM, Haas JD. Efficacy of iron supplementation may be misinterpreted using conventional measures of iron status in iron-depleted, nonanemic women undergoing aerobic exercise training. Am J Clin Nutr. 2017 Dec;106(6):1529-1538. doi: 10.3945/ajcn.117.152777. Epub 2017 Nov 1.

  PMID: 29092885 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jere Haas, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 23, 2016
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 23, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)