Iron-deficiencyNCT04793906
Meals to Improve Absorption of Iron Supplements
A study testing Iron supplement with a lunch meal containing beef and Iron supplement with a lunch meal containing plant-based alternative in people with Iron-deficiency and Iron Deficiency Anemia, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
- What is being tested?
- Iron supplement with a lunch meal containing beef and Iron supplement with a lunch meal containing plant-based alternative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 1 Nov 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9 kg/m^2)
- Low iron stores (serum ferritin <25 μg/L)
- Willing to refrain from smoking and >2 alcoholic drinks/week for the duration of the study period
- Willing to refrain from vitamin and mineral supplementation for the duration of the study
Who cannot join
- Currently smoking or vaping
- Currently taking a medication that interferes with micronutrient metabolism
- Unwilling to refrain from vitamin and mineral supplementation for the duration of the study
- Restrictive diets (i.e., vegan or vegetarian diets)
- Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- History of any disease or abnormality of the gastrointestinal tract including, but not limited to, diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
- Blood donation within 4 months of beginning the study
- Abnormal blood clotting
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial
One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Thus, nutritional strategies to improve/maintain iron status are warranted. Dietary iron is found in two different forms: heme and non-heme iron. Non-heme iron is found in plant-based sources and is commonly used as a supplement and food fortificant. Absorption of non-heme iron is low compared to heme iron, which is found in animal sources, such as beef. Studies have also demonstrated that beef contains an unidentified factor that stimulates the absorption of non-heme iron. The primary objective of the proposed study is to determine the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient WRA.
- Being tested
- Iron supplement with a lunch meal containing beef, Iron supplement with a lunch meal containing plant-based alternative
- 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.
Iron supplement with a lunch meal containing beefOther
Participants will consume a lunch meal containing beef with an iron supplement for 8 weeks.
Iron supplement with a lunch meal containing plant-based alternativeOther
Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Beef | Experimental | Not described Receives: Other: Iron supplement with a lunch meal containing beef |
| Plant-based alternative | Experimental | Not described Receives: Other: Iron supplement with a lunch meal containing plant-based alternative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status
Plasma ferritin, soluble transferrin receptor, transferrin saturation, hemoglobin and hematocrit will be measured to determine iron status. Changes in measures of iron status during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Secondary outcomes (9)
Profile of Mood States (POMS)
The POMS questionnaire will be used to assess the overall mood state of the participants. Changes in the POMS during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Appetite
Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales.
Measured: Change from day 0 and day 56
Weight
Changes in body weight during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Body composition
Body composition (fat mass, fat-free mass, and total body water content) will be determined using single frequency bioimpedance spectroscopy (BIS). Changes in body composition during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Blood pressure
Changes in blood pressure during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Metabolic biomarkers
Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Plasma zinc
Changes in the plasma zinc during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Plasma vitamin B-12
Changes in the plasma vitamin B-12 during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Plasma choline
Changes in the plasma choline during the intervention will be compared between groups.
Measured: Change from day 0 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start10 May 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Hennigar, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793906
- Sponsor's protocol ID
- PBRC 2022-036
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riley TM, Weschenfelder C, Berryman CE, Hennigar SR. Higher lipoprotein(a) concentration is associated with a blunted response to iron repletion in women with low iron stores: a secondary analysis of a randomized controlled trial. J Nutr. 2026 Oct 5:101858. doi: 10.1016/j.tjnut.2026.101858. Online ahead of print.
PubMed 42833517Hennigar SR, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Weschenfelder C, Berryman CE. Improved Iron Status, but Not Protein Source, Is Related to Appetite, Satiety, and Mood in Women of Reproductive Age With Iron Deficiency: A Randomized Controlled Trial. J Nutr. 2026 Jun;156(6):101559. doi: 10.1016/j.tjnut.2026.101559. Epub 2026 Apr 28.
PubMed 42061720Weschenfelder C, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Hennigar SR, Berryman CE. Daily Consumption of Beef, Compared to Plant-Based Meat, for Eight Weeks Has No Effects on Cardiometabolic Risk Factors among Women of Reproductive Age with Low Iron Stores: A Randomized, Controlled Clinical Trial. J Nutr. 2025 Dec;155(12):4365-4372. doi: 10.1016/j.tjnut.2025.10.028. Epub 2025 Oct 24.
PubMed 41138758Hennigar SR, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Weschenfelder C, Berryman CE. Effects of consuming an iron supplement with a meal containing animal or plant-based meat on indicators of iron status and anemia in women of reproductive age with iron deficiency: a randomized, controlled study. Am J Clin Nutr. 2025 Sep;122(3):859-865. doi: 10.1016/j.ajcnut.2025.07.002. Epub 2025 Jul 7.
PubMed 40633767
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04793906
- Acronym / sponsor ID
- PBRC 2022-036
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 11 Mar 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.
One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Thus, nutritional strategies to improve/maintain iron status are warranted. Dietary iron is found in two different forms: heme and non-heme iron. Non-heme iron is found in plant-based sources and is commonly used as a supplement and food fortificant. Absorption of non-heme iron is low compared to heme iron, which is found in animal sources, such as beef. Studies have also demonstrated that beef contains an unidentified factor that stimulates the absorption of non-heme iron. The primary objective of the proposed study is to determine the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient WRA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beef | Experimental | Other: Iron supplement with a lunch meal containing beef |
| Plant-based alternative | Experimental | Other: Iron supplement with a lunch meal containing plant-based alternative |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9 kg/m^2)
- Low iron stores (serum ferritin <25 μg/L)
- Willing to refrain from smoking and >2 alcoholic drinks/week for the duration of the study period
- Willing to refrain from vitamin and mineral supplementation for the duration of the study
Key exclusion criteria (8 listed)
- Currently smoking or vaping
- Currently taking a medication that interferes with micronutrient metabolism
- Unwilling to refrain from vitamin and mineral supplementation for the duration of the study
- Restrictive diets (i.e., vegan or vegetarian diets)
- Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
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 |
|---|---|---|
| Iron supplement with a lunch meal containing beefParticipants will consume a lunch meal containing beef with an iron supplement for 8 weeks. | Other | Beef |
| Iron supplement with a lunch meal containing plant-based alternativeParticipants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks. | Other | Plant-based alternative |
Primary outcome
Iron status
Time frame: Change from day 0 and day 56
Plasma ferritin, soluble transferrin receptor, transferrin saturation, hemoglobin and hematocrit will be measured to determine iron status. Changes in measures of iron status during the intervention will be compared between groups.
9 secondary outcomes
Profile of Mood States (POMS)
Time frame: Change from day 0 and day 56
Appetite
Time frame: Change from day 0 and day 56
Weight
Time frame: Change from day 0 and day 56
Body composition
Time frame: Change from day 0 and day 56
Blood pressure
Time frame: Change from day 0 and day 56
Metabolic biomarkers
Time frame: Change from day 0 and day 56
Plasma zinc
Time frame: Change from day 0 and day 56
Plasma vitamin B-12
Time frame: Change from day 0 and day 56
Plasma choline
Time frame: Change from day 0 and day 56
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 7 Feb 2025.
- Derived from this study: PubMed 42833517Riley TM, Weschenfelder C, Berryman CE, Hennigar SR. Higher lipoprotein(a) concentration is associated with a blunted response to iron repletion in women with low iron stores: a secondary analysis of a randomized controlled trial. J Nutr. 2026 Oct 5:101858. doi: 10.1016/j.tjnut.2026.101858. Online ahead of print.
- Derived from this study: PubMed 42061720Hennigar SR, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Weschenfelder C, Berryman CE. Improved Iron Status, but Not Protein Source, Is Related to Appetite, Satiety, and Mood in Women of Reproductive Age With Iron Deficiency: A Randomized Controlled Trial. J Nutr. 2026 Jun;156(6):101559. doi: 10.1016/j.tjnut.2026.101559. Epub 2026 Apr 28.
- Derived from this study: PubMed 41138758Weschenfelder C, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Hennigar SR, Berryman CE. Daily Consumption of Beef, Compared to Plant-Based Meat, for Eight Weeks Has No Effects on Cardiometabolic Risk Factors among Women of Reproductive Age with Low Iron Stores: A Randomized, Controlled Clinical Trial. J Nutr. 2025 Dec;155(12):4365-4372. doi: 10.1016/j.tjnut.2025.10.028. Epub 2025 Oct 24.
- Derived from this study: PubMed 40633767Hennigar SR, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Weschenfelder C, Berryman CE. Effects of consuming an iron supplement with a meal containing animal or plant-based meat on indicators of iron status and anemia in women of reproductive age with iron deficiency: a randomized, controlled study. Am J Clin Nutr. 2025 Sep;122(3):859-865. doi: 10.1016/j.ajcnut.2025.07.002. Epub 2025 Jul 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron supplement with a lunch meal containing beef and Iron supplement with a lunch meal containing plant-based alternative in people with Iron-deficiency and Iron Deficiency Anemia, run by Pennington Biomedical Research Center at 1 site in United States.
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 4 inclusion and 8 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 7 Feb 2025. 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 United States. 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. 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?
Iron status (time frame: Change from day 0 and day 56). 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 NCT04793906, which also lists 4 linked publications.
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 7 Feb 2025.