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Effect of Iron-fortified Pea Powder on Exercise Performance

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ClinicalTrials.gov Identifier: NCT04872140
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Study Description
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Brief Summary:
Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study assesses the impact of an pea protein supplement with high iron bio-availability on iron status and exercise performance.

Condition or disease Intervention/treatment Phase
Iron-deficiency Dietary Supplement: Low phytate pea powder Dietary Supplement: Regular pea powder Dietary Supplement: Placebo (maltodextrin) Not Applicable

Detailed Description:
Female endurance athletes are susceptible to iron deficiency due to poor iron intake from diets or possibly because of destruction of red blood cells during foot-strike hemolysis. This study will evaluate the impact of 8-weeks of iron supplementation through consumption of a pea-protein power that has high iron bio-availability due to low phytate levels. This will be compared to consumption of regular iron protein powder and maltodextrin placebo by randomizing participants to three groups. Participants will be assessed at baseline and after 8 weeks of supplementation for exercise performance (maximal aerobic capacity and a 5 km time trial running test), blood levels of ferritin and hemoglobin, and body composition (fat mass and lean tissue mass).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants are being randomized to three groups for the 8-week intervention:

  1. Pea power with high iron bio-availability
  2. Regular pea powder
  3. Placebo (maltodextrin)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The powder supplements are being administered in a blinded manner. An individual who is separate from the rest of the research team will generate the allocation schedule and prepare the supplement packages so that participants, investigators, and outcome assessors are blinded. Statistical analysis will be blinded by coding of groups
Primary Purpose: Treatment
Official Title: Effect of Low-phytate Pea Powder With High Iron Bioavailability on Iron Status of Female Runners
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pea power with high iron bio-availability
Pea powder with low phytate levels to increase iron bio-availability (7mg iron per day)
 Dietary Supplement: Low phytate pea powder
Exercise performance with low phytate pea powder
Active Comparator: Pea powder
Pea powder with normal phytate levels (7mg iron per day)
 Dietary Supplement: Regular pea powder
Exercise performance with regular pea powder
Placebo Comparator: Placebo
Placebo (maltodextrin) powder (0g iron per day)
 Dietary Supplement: Placebo (maltodextrin)
Exercise performance with placebo (maltodextrin)


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in ferritin levels [ Time Frame: Up to 8 weeks ]
    blood ferritin levels


Secondary Outcome Measures :
  1. Change from baseline in maximal aerobic capacity [ Time Frame: Up to 8 weeks ]
    Maximal aerobic capacity (mL/kg/min) measured on a treadmill

  2. Change from baseline in exercise time trial performance [ Time Frame: Up to 8 weeks ]
    Time (minutes) to complete 5 km running on a treadmill

  3. Change from baseline in hemoglobin levels [ Time Frame: Up to 8 weeks ]
    Blood hemoglobin concentration

  4. Change from baseline in lean tissue mass [ Time Frame: Up to 8 weeks ]
    Lean tissue mass (kg) measured with dual energy X-ray absorptiometry

  5. Change from baseline in fat mass [ Time Frame: Up to 8 weeks ]
    Fat mass (kg) measured with dual energy X-ray absorptiometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Regularly participate in aerobic endurance training

Exclusion Criteria:

  • Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872140


Contacts
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Contact: Philip Chilibeck, PhD 1-306-343-6577 phil.chilibeck@usask.ca

Locations
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Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N5B2
Contact: Philip Chilibeck, PhD    1-306-343-6577    phil.chilibeck@usask.ca   
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
More Information
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Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04872140    
Other Study ID Numbers: 1207
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
 Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases