Iron and Zinc Bioavailability From Biofortified Potatoes

NCT05154500 | Completed

• 1 other identifier: BB/S014039/1
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 2

Brief Summary

Two of the most common nutritional deficiencies are anemia and zinc deficiency. One strategy for combating nutritional deficiencies is biofortification. The primary objective of the proposed research is to determine in humans the bioavailability of iron and zinc from biofortified potatoes as compared to a non-fortified local variety. The secondary objective is to use the data obtained from the human studies to model the potential impact of the introduction of biofortified potatoes to the alleviation of iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere. Iron bioavailability studies: The investigators will compare bioavailability of iron from a non-fortified potato variety with a biofortified potato that has significantly higher iron content though the use of a randomized cross-over intervention study. Female volunteers will consume both biofortified potato extrinsically labelled with 58FeSO4 and a nonfortified potato labelled with 57FeSO4. Thirty women with marginal iron status (plasma ferritin \< 25 ng/ml) will be selected from an initial screening of 180 women. Every woman will receive 2 different types of test meals in a series of 20 servings for 10 days each. Blood samples will be collected during screening and on days 1, 15, 26 and 40 and the amount of 58Fe and 57Fe incorporated into hemoglobin and serum ferritin quantified. Zinc bioavailability study: The investigators will compare bioavailability of zinc from a non-fortified potato variety with that of a biofortified potato that has significantly higher zinc content (p\<0.001) with a crossover study. Forty volunteers will be randomly assigned to receive first either the biofortified or the non-fortified potato and receive the second meal 30 days later. Zinc absorption from two meals will be measured using the double stable isotope technique. Every volunteer will be given an i.v. infusion of 70zinc and two test meals of 250 g cooked potato labelled extrinsically with 67zinc separated by 3-4 hr. A spot urine sample will be collected 96 hours after each set of test meal and the ratio of the two isotopes measured to calculate absorption of zinc from the test meal. Modelling and Impact assessment: Data on bioavailability will be used in a Disability Adjusted Life Year model to assess the potential impact of biofortified potatoes to alleviate iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere.

Conditions

Biofortification; Potato

Keywords

Biofortification; Zinc; Iron; Potato

Outcome Measures

Primary Outcomes (1)

• Percent of iron absorption from a biofortified potato vs non-biofortified potato

  Percent of of iron absorption from a biofortified potato is higher as compared to a non-fortified local variety.

  40 days

Secondary Outcomes (1)

• Percent of zinc absorption from a biofortified potato vs non-biofortified potato

  35 days

Study Arms (2)

Biofortified Potato with iron or zinc ('A')

EXPERIMENTAL

Women volunteers will consume biofortified ('A') for one day in zinc study, and 10 days in iron study Zinc study and a local non-fortified Peruanita potato variety ('B') in a randomized order (either A-B or B-A). The potatoes have significantly different (p\<0.001) content of iron or zinc, but no significant differences in vitamin C or phenolics (p\>0.05). Based on this study design, every woman is her own control.

Other: Iron biofortified potato; Other: Zinc biofortified potato

Non Biofortified potato with iron or zinc ('B')

PLACEBO COMPARATOR

Women volunteers will consume no biofortified ('B') for one day in zinc study, and 10 days in iron study

Other: Iron biofortified potato; Other: Zinc biofortified potato

Interventions

Iron biofortified potato OTHER

A non-blinded randomized cross-over design with multiple meal feedings will be used to quantify iron bioavailability from iron biofortified and non-biofortified potatoes. Women volunteers will consume biofortified ('A') and a local non-fortified Peruanita potato variety ('B') in a randomized order (either A-B or B-A). The potatoes have significantly different (p\<0.001) content of iron or zinc, but no significant differences in vitamin C or phenolics (p\>0.05). Based on this study design, every woman is her own control.

Biofortified Potato with iron or zinc ('A'); Non Biofortified potato with iron or zinc ('B')

Zinc biofortified potato OTHER

A crossover study will be used to compare zinc bioavailability of biofortified and non-fortified potatoes. Nutritional pre-screening is not required as there are no major systemic influences on zinc absorption.Volunteers will be randomly assigned to consume first either the biofortified or the non-biofortified potato, and consume the second potato-type 30 days later. Zinc absorption from two meals of biofortified or non-fortified potato will be measured using the double stable isotope technique.

Biofortified Potato with iron or zinc ('A'); Non Biofortified potato with iron or zinc ('B')

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Inclusión Criteria:
• Healthy women aged 18-45 years
• Marginal levels of iron in blood as measured by serum ferritin \<25ug/L.
• BMI: 18.5 to 25 kg/m2.
• Body weight \<65kg.
• Prepared to attend study visits at the investigator site over a period of approximately 4 weeks (total 20 days) and, eat each day the prepared potatoes and then stay for a further 3 hours after eating the potato.
• Able to understand study requirements and provide written informed consent.

You may not qualify if:

• Severe anaemia (Hb\<80g/L)
• Evidence of inflammation as measured by C-reactive protein (CRP) (\>5mg/100ml).
• Gastrointestinal or renal problems; self-reported metabolic disease based on prior diagnosis, or a prior screening questionnaire.
• Pregnancy (positive urine test).
• Currently breastfeeding.
• Currently taking any medication, antibiotic or supplement that might be expected to affect iron metabolism.
• Not willing to discontinue taking iron supplements for at least 2 weeks before taking part in the study.
• No significant blood loss in the last 6 months due to trauma, major surgery or blood donation.
• Not able to eat the full amount of the potato.
• Allergy to any ingredients of the test meal.
• Healthy women aged 18-45 years.
• BMI 18.5-25 kg/m2.
• Willing to come to the study centre to eat the prepared potatoes on two occasions with a wash-out of 30 days (each day a different variety of potato) and to remain in the study centre for 7-8 hours in both occasions (one day to eat the biofortified variety and the other day the common variety) and as well to comply with all the study processes.
• Able to understand the consent form and to sign it.
• Severe anaemia (Hb\<80g/dL adjusted for altitude).

Sponsors & Collaborators

• Instituto de Investigacion Nutricional, Peru: lead
• Quadram Institute Bioscience: collaborator
• University of East Anglia: collaborator

Study Sites (2)

International Potato Center

Lima, 15024, Peru

Location

Research Nutritional Institute

Lima, 15024, Peru

Location

Related Publications (2)

• Liria-Dominguez R, Penny M, Kroon PA, Burgos G, Dainty J, Zeder C, Zimmermann MB, King J, Mithen R, Boy E, Al-Jaiballi O, Fairweather-Tait S. Biofortified Yellow-Fleshed Potatoes Provide More Absorbable Zinc than a Commonly Consumed Variety: A Randomized Trial Using Stable Isotopes in Women in the Peruvian Highlands. J Nutr. 2023 Oct;153(10):2893-2900. doi: 10.1016/j.tjnut.2023.08.028. Epub 2023 Aug 28.

  PMID: 37648112 DERIVED

• Burgos G, Liria R, Zeder C, Kroon PA, Hareau G, Penny M, Dainty J, Al-Jaibaji O, Boy E, Mithen R, Hurrell RF, Salas E, Zum Felde T, Zimmermann MB, Fairweather-Tait S. Total Iron Absorbed from Iron-Biofortified Potatoes Is Higher than that from Nonbiofortified Potatoes: A Randomized Trial Using Stable Iron Isotopes in Women from the Peruvian Highlands. J Nutr. 2023 Jun;153(6):1710-1717. doi: 10.1016/j.tjnut.2023.04.010. Epub 2023 Apr 13.

  PMID: 37059395 DERIVED

Study Officials

• Reyna Liria-Domínguez, PhD

  Instituto de Investigación Nutricional

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized trial of naturally biofortified with iron or zinc potatoes to be carried out in Huancavelica.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 13, 2021
• Study Start: August 29, 2018
• Primary Completion: November 30, 2021
• Study Completion: March 31, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2)