Iron Bioavailability From Cereal-based Foods

NCT05061290 | Unknown

• 1 other identifier: IRB-2019-764
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Iron Bioavailability

Outcome Measures

Primary Outcomes (1)

• Iron absorption

  Assessment whole blood for isotopic iron absorption from individual meals

  Acute study but blood measurement to occur following 14 daysof acute consumption

Study Arms (5)

Control Porridge

EXPERIMENTAL

Wholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Corn starch

Other: Control Porridge

Reference Porride A

EXPERIMENTAL

Wholegrain maize flour, Mango powder, Carrot powder, Ferrous sulfate, Ascorbic acid, Corn starch

Other: Reference Porridge A

Test Porridge B

EXPERIMENTAL

Wholegrain maize flour, Moringa leaf powder, Mango powder, Carrot powder, Corn starch

Other: Test Porridge B

Test Porridge C

EXPERIMENTAL

Wholegrain maize flour, Baobab fruit powder, Mango powder, Carrot powder, Ferrous sulfate, Corn starch

Other: Test Porridge C

Test Porridge D

EXPERIMENTAL

Wholegrain maize flour, Baobab fruit powder, Moringa leaf powder, Mango powder, Carrot powder

Other: Test Porridge D

Interventions

Control Porridge OTHER

Maize porridge containing 54Fe as iron sulfate

Control Porridge

Reference Porridge A OTHER

Maize porridge counting 58Fe as iron sulfate with ascorbic acid

Reference Porride A

Test Porridge B OTHER

Maize porridge containing 57Fe and fortified with Moringa leaf powder as iron source

Test Porridge B

Test Porridge C OTHER

Maize porridge containing 57Fe and fortified with Boabab fruit powder as iron source

Test Porridge C

Test Porridge D OTHER

Maize porridge containing 54Fe and fortified with Moringa leaf and Baobab fruit powder as iron source

Test Porridge D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Purdue University: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Central Study Contacts

Bruce Hamaker

CONTACT

7654945668; hamakerb@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: November 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)