NCT04872140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

April 23, 2021

Last Update Submit

October 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in ferritin levels

    blood ferritin levels

    Up to 8 weeks

Secondary Outcomes (5)

  • Change from baseline in maximal aerobic capacity

    Up to 8 weeks

  • Change from baseline in exercise time trial performance

    Up to 8 weeks

  • Change from baseline in hemoglobin levels

    Up to 8 weeks

  • Change from baseline in lean tissue mass

    Up to 8 weeks

  • Change from baseline in fat mass

    Up to 8 weeks

Study Arms (3)

Pea power with high iron bio-availability

EXPERIMENTAL

Pea powder with low phytate levels to increase iron bio-availability (7mg iron per day)

Dietary Supplement: Low phytate pea powder

Pea powder

ACTIVE COMPARATOR

Pea powder with normal phytate levels (7mg iron per day)

Dietary Supplement: Regular pea powder

Placebo

PLACEBO COMPARATOR

Placebo (maltodextrin) powder (0g iron per day)

Dietary Supplement: Placebo (maltodextrin)

Interventions

Low phytate pea powderDIETARY_SUPPLEMENT

Exercise performance with low phytate pea powder

Pea power with high iron bio-availability
Regular pea powderDIETARY_SUPPLEMENT

Exercise performance with regular pea powder

Pea powder
Placebo (maltodextrin)DIETARY_SUPPLEMENT

Exercise performance with placebo (maltodextrin)

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Regularly participate in aerobic endurance training

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

Related Publications (1)

  • Shaw KA, Chilibeck PD, Lindsay DL, Warkentin TD, Ko J, Zello GA. Low phytic acid pea supplementation as an approach to combating iron deficiency in female runners: A randomized control trial. Nutr Health. 2025 Mar;31(1):293-301. doi: 10.1177/02601060231181605. Epub 2023 Jun 8.

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Philip Chilibeck, Ph.D.

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 4, 2021

Study Start

May 3, 2021

Primary Completion

June 30, 2022

Study Completion

August 15, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations