IP Peru, Bioavailability of Iron From Potatoes

NCT04216030 | Completed

• 1 other identifier: 1267-USAI-000-ETH-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Irish Potato (IP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron IP variety and a normal market level IP variety. The study is conducted in Peruvian women of reproductive age with marginal iron status.

Conditions

Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency (Without Anemia)

Keywords

Biofortification; Staple crops; Stable isotope studies

Outcome Measures

Primary Outcomes (2)

• Fractional iron absorption from both Irish Potato test meals

  Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period

  Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.

• Total iron absorption from both Irish Potato test meals

  Amount of iron absorbed (mg) from the labelled test meals

  Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.

Secondary Outcomes (2)

• Concentration of plasma ferritin level

  screening (-1), day 1 (baseline), day 15 (before switch to other test meal type) day 26 (last feeding day) and day 40 (14 days after last test meal consumption).

• Concentration of plasma CRP level

  screening (-1), day 1 (baseline), day 15 (before switch to other test meal type) day 26 (last feeding day) and day 40 (14 days after last test meal consumption).

Study Arms (2)

High iron Irish potato

EXPERIMENTAL

Meal sequence B, IP High Fe

Other: High Fe IP meal labelled with Fe-58

Regular Irish potato

ACTIVE COMPARATOR

Meal sequence A, OFSP control

Other: Control OFSP meal labelled with Fe-57

Interventions

High Fe IP meal labelled with Fe-58 OTHER

500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days

High iron Irish potato

Control OFSP meal labelled with Fe-57 OTHER

500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days

Regular Irish potato

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman aged 18-25 years old.
• Low/marginal iron status: serum ferritin (SF) ≤ 25 μg/L.
• Normal BMI for age (18.5-25.0 kg/m2).
• Weight less than 65 kg. We will give equal amounts of stable isotopes to each study participant and therefore need to set a limit on body weight in order to achieve measurable isotope enrichment in erythrocytes.
• Willing and able to commute to the meal distribution/health centre site.
• Able to understand and to sign written concept prior to trial entry.
• Informed consent signed.
• Prepared to use contraceptives for the duration of the study

You may not qualify if:

• Severe anaemia Hb \<107.2 g/L (adjusted for meters above sea level)
• Inflammation/infection (CRP \> 5 mg/100 ml).
• Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, and any other problem that will interfere with the study as determined by the screening visit and by self-report from the subjects.
• Pregnant (urine test before entering the study) or breast-feeding.
• Any medication or supplement which may impact iron metabolism.
• Unwilling to discontinue vitamin and minerals supplements at least two weeks prior to the study start, as ascertained at the screening visit.
• Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation).
• Subject who cannot be expected to comply with study procedures.
• Presence of fever (\>37.5 °C) on the first study day

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Genetics, Genomics and Crop Improvement Program, International Potato Center, Lima, Peru: collaborator
• United States Agency for International Development (USAID): collaborator
• Quadram Institute Bioscience: collaborator
• Instituto de Investigacion Nutricional, Lima, Peru: collaborator

Study Sites (1)

Instituto de Investigacion Nutricional

Lima, 1506, Peru

Location

Related Publications (1)

• Jongstra R, Mwangi MN, Burgos G, Zeder C, Low JW, Mzembe G, Liria R, Penny M, Andrade MI, Fairweather-Tait S, Zum Felde T, Campos H, Phiri KS, Zimmermann MB, Wegmuller R. Iron Absorption from Iron-Biofortified Sweetpotato Is Higher Than Regular Sweetpotato in Malawian Women while Iron Absorption from Regular and Iron-Biofortified Potatoes Is High in Peruvian Women. J Nutr. 2020 Dec 10;150(12):3094-3102. doi: 10.1093/jn/nxaa267.

  PMID: 33188398 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Reyna Liria

  INN

  PRINCIPAL INVESTIGATOR

• Mary Penny

  INN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participant is non-blinded based on differences in meal option A and B, meal option A --\> B or B --\> A, is assigned through investigator randomisation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each woman consumes both high-iron Irish potato and a regular Irish potato variety.

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 2, 2020
• Study Start: May 14, 2019
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)