Iron BioavailabilityNCT05061290
Iron Bioavailability From Cereal-based Foods
A study testing Reference Porridge A, Test Porridge B and Test Porridge C in people with Iron Bioavailability, run by Purdue University at 1 site in United States.
Trial summary
Iron-deficient anemia is a chronic problem in sub-Saharan Africa and other developing areas of the world. From our previous research, the investigators have shown that certain local plant foods in Kenya and Senegal have an unusual action of improving in vitro iron bioaccessibility (nearly doubling the low value… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Bioavailability
- What is being tested?
- Reference Porridge A, Test Porridge B and Test Porridge C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2022to Feb 2023
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female 18-65 Y
- BMI 18.5-25 kg/m2
- Stable weight past 3 month (+/- 2.5kg)
- Clinically normal blood profiles
- Fasting blood glucose < 110 and CRP below 3 mg/L
Who cannot join
- Smokers and vapers
- No heavy alcohol consumption (>2 drinks per day)
- Diabetic
- Presence of metabolic of intestinal disorder including lipid malabsorption or lactose intolerance
- Male sex
- Pregnant
Show all 14Show fewer
- Lactating
- Long term use of medications
- Blood donation in past 4 months
- Previous participation in iron stable isotope bioavailability study
- Following a weight reduction program or having one in past 3 months
- Peri- or post-menopausal
- Acute or chronic disease
- Hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University
West Lafayette, Indiana, 47907
Bruce R Hamaker, PhD, 765-494-5668, hamakerb@purdue.edu
About this study
Official title: The Potential of Food to Food Fortification to Improve Iron Bioavailability From Cereal-based Foods
Iron-deficient anemia is a chronic problem in sub-Saharan Africa and other developing areas of the world. From our previous research, the investigators have shown that certain local plant foods in Kenya and Senegal have an unusual action of improving in vitro iron bioaccessibility (nearly doubling the low value obtained in cereals). The investigators will assess absorption of stable isotopes of iron (57Fe, 54Fe and 58Fe) extrinsically labeled in a serving of porridge fortified with various combinations of moringa, baobab, mango, carrot and standard fortificant iron sulfate and the enhancer ascorbic acid.
Read the detailed description
To better understand the potential for leveraging traditional plant-based ingredients in local fortification efforts in Africa, the proposed study will focus on assessment of acute iron bioavailability in participants consuming instant blended cereal porridges produced using whole grain white maize, with provitamin A (e.g. carrots/mango), moringa leaf powder and baobab fruit powder in specific combinations. The investigators hypothesize that: food-to-food fortified cereal-based porridge with with African baobab fruit and moringa leaf powder will effectively improve iron density and bioavailability in human participants as compared to a "gold standard" fortification (iron sulphate and ascorbic acid).
A randomized crossover design with 4 different white maize cereal-based porridges and a reference control porridge (with matching macronutrient contents) will be used, allowing each participant to serve as their own control. Porridges are designed to specifically compare: (1) Food to food fortification versus standard fortifications and (2) the ability of baobab fruit pulp to enhance iron absorption from both natural and standard sources. The porridges will be composed of locally sourced ingredients including: whole grain white maize, a pro-vitamin A source (oil and available vegetables e.g. carrot and mango) baobab fruit powder and moringa leaf powder.
The enrolled participants will come into the clinic 6 times to consume porridges or have blood drawn. Four times blood (1 for screening, 3 for study) will be drawn to determine the amount of the different forms of iron in participant's blood. On each day of porridge consumption (each visit except the final visit on Day 33), they will consume 2 x 350 g porridge meals and stay 90 mins after the participant has finished each of the meals, and then leave and come back to repeat for a total of 4 hours. After two weeks they will return to the clinic and the investigators will ask to draw some more blood to see if they have absorbed any of the different forms of iron. They will then have the next porridge. Importantly for each visit for both blood draws and the porridge consumption the participants will have to fast the previous night, so no food or beverages like tea or coffee can be consumed (only water allowed). During 5 visits when they will eat two portions of porridge during the day and will have to stay at the facility for 90 mins after each porridge consumption. During the last visit (Day 33), participants will need to give a blood sample, which will take about half an hour. Blood collected during these visits will be used to measure isotopic iron absorbed from the porridges.
- Conditions
- Iron Bioavailability
- Being tested
- Control Porridge, Reference Porridge A, Test Porridge B, Test Porridge C, Test Porridge D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control PorridgeOther
Maize porridge containing 54Fe as iron sulfate
Reference Porridge AOther
Maize porridge counting 58Fe as iron sulfate with ascorbic acid
Test Porridge BOther
Maize porridge containing 57Fe and fortified with Moringa leaf powder as iron source
Test Porridge COther
Maize porridge containing 57Fe and fortified with Boabab fruit powder as iron source
Test Porridge DOther
Maize porridge containing 54Fe and fortified with Moringa leaf and Baobab fruit powder as iron source
| Study group | Role | What they receive |
|---|---|---|
| Control Porridge | Experimental | Wholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Corn starch Receives: Other: Control Porridge |
| Reference Porride A | Experimental | Wholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Ascorbic acid, Corn starch Receives: Other: Reference Porridge A |
| Test Porridge B | Experimental | Wholegrain maize flour, Moringa leaf powder, Mango powder, Carrot powder, Corn starch Receives: Other: Test Porridge B |
| Test Porridge C | Experimental | Wholegrain maize flour, Baobab fruit powder, Mango powder, Carrot powder, Ferrous sulfate, Corn starch Receives: Other: Test Porridge C |
| Test Porridge D | Experimental | Wholegrain maize flour, Baobab fruit powder, Moringa leaf powder, Mango powder, Carrot powder Receives: Other: Test Porridge D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorption
Assessment whole blood for isotopic iron absorption from individual meals
Measured: Acute study but blood measurement to occur following 14 daysof acute consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startNov 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron BioavailabilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061290
- Sponsor's protocol ID
- IRB-2019-764
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Food to Food Fortification to Improve Iron Bioavailability From Cereal-based Foods
- ClinicalTrials.gov ID
- NCT05061290
- Acronym / sponsor ID
- IRB-2019-764
- Conditions
- Iron Bioavailability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 29 Sep 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.
Iron-deficient anemia is a chronic problem in sub-Saharan Africa and other developing areas of the world. From our previous research, the investigators have shown that certain local plant foods in Kenya and Senegal have an unusual action of improving in vitro iron bioaccessibility (nearly doubling the low value obtained in cereals). The investigators will assess absorption of stable isotopes of iron (57Fe, 54Fe and 58Fe) extrinsically labeled in a serving of porridge fortified with various combinations of moringa, baobab, mango, carrot and standard fortificant iron sulfate and the enhancer ascorbic acid.
Detailed description
To better understand the potential for leveraging traditional plant-based ingredients in local fortification efforts in Africa, the proposed study will focus on assessment of acute iron bioavailability in participants consuming instant blended cereal porridges produced using whole grain white maize, with provitamin A (e.g. carrots/mango), moringa leaf powder and baobab fruit powder in specific combinations. The investigators hypothesize that: food-to-food fortified cereal-based porridge with with African baobab fruit and moringa leaf powder will effectively improve iron density and bioavailability in human participants as compared to a "gold standard" fortification (iron sulphate and ascorbic acid).
A randomized crossover design with 4 different white maize cereal-based porridges and a reference control porridge (with matching macronutrient contents) will be used, allowing each participant to serve as their own control. Porridges are designed to specifically compare: (1) Food to food fortification versus standard fortifications and (2) the ability of baobab fruit pulp to enhance iron absorption from both natural and standard sources. The porridges will be composed of locally sourced ingredients including: whole grain white maize, a pro-vitamin A source (oil and available vegetables e.g. carrot and mango) baobab fruit powder and moringa leaf powder.
The enrolled participants will come into the clinic 6 times to consume porridges or have blood drawn. Four times blood (1 for screening, 3 for study) will be drawn to determine the amount of the different forms of iron in participant's blood. On each day of porridge consumption (each visit except the final visit on Day 33), they will consume 2 x 350 g porridge meals and stay 90 mins after the participant has finished each of the meals, and then leave and come back to repeat for a total of 4 hours. After two weeks they will return to the clinic and the investigators will ask to draw some more blood to see if they have absorbed any of the different forms of iron. They will then have the next porridge. Importantly for each visit for both blood draws and the porridge consumption the participants will have to fast the previous night, so no food or beverages like tea or coffee can be consumed (only water allowed). During 5 visits when they will eat two portions of porridge during the day and will have to stay at the facility for 90 mins after each porridge consumption. During the last visit (Day 33), participants will need to give a blood sample, which will take about half an hour. Blood collected during these visits will be used to measure isotopic iron absorbed from the porridges.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Porridge | Experimental | Other: Control PorridgeWholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Corn starch |
| Reference Porride A | Experimental | Other: Reference Porridge AWholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Ascorbic acid, Corn starch |
| Test Porridge B | Experimental | Other: Test Porridge BWholegrain maize flour, Moringa leaf powder, Mango powder, Carrot powder, Corn starch |
| Test Porridge C | Experimental | Other: Test Porridge CWholegrain maize flour, Baobab fruit powder, Mango powder, Carrot powder, Ferrous sulfate, Corn starch |
| Test Porridge D | Experimental | Other: Test Porridge DWholegrain maize flour, Baobab fruit powder, Moringa leaf powder, Mango powder, Carrot powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female 18-65 Y
- BMI 18.5-25 kg/m2
- Stable weight past 3 month (+/- 2.5kg)
- Clinically normal blood profiles
- Fasting blood glucose < 110 and CRP below 3 mg/L
Key exclusion criteria (14 listed)
- Smokers and vapers
- No heavy alcohol consumption (>2 drinks per day)
- Diabetic
- Presence of metabolic of intestinal disorder including lipid malabsorption or lactose intolerance
- Male sex
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 |
|---|---|---|
| Control PorridgeMaize porridge containing 54Fe as iron sulfate | Other | Control Porridge |
| Reference Porridge AMaize porridge counting 58Fe as iron sulfate with ascorbic acid | Other | Reference Porride A |
| Test Porridge BMaize porridge containing 57Fe and fortified with Moringa leaf powder as iron source | Other | Test Porridge B |
| Test Porridge CMaize porridge containing 57Fe and fortified with Boabab fruit powder as iron source | Other | Test Porridge C |
| Test Porridge DMaize porridge containing 54Fe and fortified with Moringa leaf and Baobab fruit powder as iron source | Other | Test Porridge D |
Primary outcome
Iron absorption
Time frame: Acute study but blood measurement to occur following 14 daysof acute consumption
Assessment whole blood for isotopic iron absorption from individual meals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference Porridge A, Test Porridge B and Test Porridge C in people with Iron Bioavailability, run by Purdue University 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruce Hamaker (7654945668, hamakerb@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron absorption (time frame: Acute study but blood measurement to occur following 14 daysof acute consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.