Iron and Zinc Bioavailability From Biofortified Potatoes

NCT05154500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2023-01-25

No results posted yet for this study

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

Interventions

OTHER

Iron biofortified potato

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.

OTHER

Zinc biofortified potato

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.

Sponsors & Collaborators

  • Quadram Institute Bioscience

    collaborator OTHER
  • University of East Anglia

    collaborator OTHER
  • Instituto de Investigacion Nutricional, Peru

    lead OTHER

Principal Investigators

  • Reyna Liria-Domínguez, PhD · Instituto de Investigación Nutricional

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2021-11-30
Completion
2022-03-31

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154500 on ClinicalTrials.gov