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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04872140
Other study ID # 1207
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date August 15, 2022

Study information

Verified date October 2022
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 15, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Female - Regularly participate in aerobic endurance training Exclusion Criteria: - Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Low phytate pea powder
Exercise performance with low phytate pea powder
Regular pea powder
Exercise performance with regular pea powder
Placebo (maltodextrin)
Exercise performance with placebo (maltodextrin)

Locations

Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in ferritin levels blood ferritin levels Up to 8 weeks
Secondary Change from baseline in maximal aerobic capacity Maximal aerobic capacity (mL/kg/min) measured on a treadmill Up to 8 weeks
Secondary Change from baseline in exercise time trial performance Time (minutes) to complete 5 km running on a treadmill Up to 8 weeks
Secondary Change from baseline in hemoglobin levels Blood hemoglobin concentration Up to 8 weeks
Secondary Change from baseline in lean tissue mass Lean tissue mass (kg) measured with dual energy X-ray absorptiometry Up to 8 weeks
Secondary Change from baseline in fat mass Fat mass (kg) measured with dual energy X-ray absorptiometry Up to 8 weeks
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