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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Bruce Hamaker contact

7654945668

hamakerb@purdue.edu

United States1 site
  • Purdue University

    West Lafayette, Indiana, 47907

    Bruce R Hamaker, PhD, 765-494-5668, hamakerb@purdue.edu

Other trials in United States

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.

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 groups in NCT05061290
Study groupRoleWhat they receive
Control PorridgeExperimentalWholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Corn starch
Receives: Other: Control Porridge
Reference Porride AExperimentalWholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Ascorbic acid, Corn starch
Receives: Other: Reference Porridge A
Test Porridge BExperimentalWholegrain maize flour, Moringa leaf powder, Mango powder, Carrot powder, Corn starch
Receives: Other: Test Porridge B
Test Porridge CExperimentalWholegrain maize flour, Baobab fruit powder, Mango powder, Carrot powder, Ferrous sulfate, Corn starch
Receives: Other: Test Porridge C
Test Porridge DExperimentalWholegrain 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.

  1. 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.

  1. First posted29 Sep 2021
  2. Study startNov 2022 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

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)
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

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.

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