Iron-deficiencyNCT04872140
Effect of Iron-fortified Pea Powder on Exercise Performance
A study testing Low phytate pea powder and Regular pea powder in people with Iron-deficiency, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Low phytate pea powder and Regular pea powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Regularly participate in aerobic endurance training
Who cannot join
- Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Iron-deficiency
- Being tested
- Low phytate pea powder, Regular pea powder, Placebo (maltodextrin)
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low phytate pea powderDietary supplement
Exercise performance with low phytate pea powder
Regular pea powderDietary supplement
Exercise performance with regular pea powder
Placebo (maltodextrin)Dietary supplement
Exercise performance with placebo (maltodextrin)
| Study group | Role | What they receive |
|---|---|---|
| Pea power with high iron bio-availability | Experimental | Pea powder with low phytate levels to increase iron bio-availability (7mg iron per day) Receives: Dietary Supplement: Low phytate pea powder |
| Pea powder | Active comparator | Pea powder with normal phytate levels (7mg iron per day) Receives: Dietary Supplement: Regular pea powder |
| Placebo | Placebo comparator | Placebo (maltodextrin) powder (0g iron per day) Receives: Dietary Supplement: Placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ferritin levels
blood ferritin levels
Measured: Up to 8 weeks
Secondary outcomes (5)
Change from baseline in maximal aerobic capacity
Maximal aerobic capacity (mL/kg/min) measured on a treadmill
Measured: Up to 8 weeks
Change from baseline in exercise time trial performance
Time (minutes) to complete 5 km running on a treadmill
Measured: Up to 8 weeks
Change from baseline in hemoglobin levels
Blood hemoglobin concentration
Measured: Up to 8 weeks
Change from baseline in lean tissue mass
Lean tissue mass (kg) measured with dual energy X-ray absorptiometry
Measured: Up to 8 weeks
Change from baseline in fat mass
Fat mass (kg) measured with dual energy X-ray absorptiometry
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start3 May 2021
- Primary completion30 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, Ph.D., Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872140
- Sponsor's protocol ID
- 1207
- Status last verified
- Oct 2022
- First submitted
- 23 Apr 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37291968
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-phytate Pea Powder With High Iron Bioavailability on Iron Status of Female Runners
- ClinicalTrials.gov ID
- NCT04872140
- Acronym / sponsor ID
- 1207
- Conditions
- Iron-deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Pea power with high iron bio-availability | Experimental | Dietary Supplement: Low phytate pea powderPea powder with low phytate levels to increase iron bio-availability (7mg iron per day) |
| Pea powder | Active comparator | Dietary Supplement: Regular pea powderPea powder with normal phytate levels (7mg iron per day) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)Placebo (maltodextrin) powder (0g iron per day) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- Regularly participate in aerobic endurance training
Key exclusion criteria (1 listed)
- Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low phytate pea powderExercise performance with low phytate pea powder | Dietary supplement | Pea power with high iron bio-availability |
| Regular pea powderExercise performance with regular pea powder | Dietary supplement | Pea powder |
| Placebo (maltodextrin)Exercise performance with placebo (maltodextrin) | Dietary supplement | Placebo |
Primary outcome
Change from baseline in ferritin levels
Time frame: Up to 8 weeks
blood ferritin levels
5 secondary outcomes
Change from baseline in maximal aerobic capacity
Time frame: Up to 8 weeks
Change from baseline in exercise time trial performance
Time frame: Up to 8 weeks
Change from baseline in hemoglobin levels
Time frame: Up to 8 weeks
Change from baseline in lean tissue mass
Time frame: Up to 8 weeks
Change from baseline in fat mass
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 37291968Shaw 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.
- Individual participant dataSharing planned: No
Related trials for Iron-deficiency
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chilibeck, Ph.D. principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low phytate pea powder and Regular pea powder in people with Iron-deficiency, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ferritin levels (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.