Effect of Iron-fortified Pea Powder on Exercise Performance

October 11, 2022 updated by: Phil Chilibeck, University of Saskatchewan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N5B2
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in ferritin levels
Time Frame: Up to 8 weeks
blood ferritin levels
Up to 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 3, 2021

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

August 15, 2022

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (ACTUAL)

May 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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