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Completed

NCT Number: NCT04872140

Effect of Iron-fortified Pea Powder on Exercise Performance

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Regularly participate in aerobic endurance training

Exclusion criteria

  • Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"

Treatment and study plan

Low phytate pea powder

Dietary Supplement

Exercise performance with low phytate pea powder

Regular pea powder

Dietary Supplement

Exercise performance with regular pea powder

Placebo (Maltodextrin)

Dietary Supplement

Exercise performance with placebo (maltodextrin)

Primary outcomes

  1. Change from baseline in ferritin levels

    Time frame: Up to 8 weeks

    blood ferritin levels

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Effect of Low-phytate Pea Powder With High Iron Bioavailability on Iron Status of Female Runners

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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