NCT05154500

Iron and Zinc Bioavailability From Biofortified Potatoes

Completed NA Last updated 25 January 2023

What this trial tests

NA trial testing Iron biofortified potato in Biofortification in 179 participants. Completed in 31 March 2022.

Timeline

29 August 2018

Primary endpoint
30 November 2021

31 March 2022

Quick facts

Lead sponsor	Instituto de Investigacion Nutricional, Peru
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	179
Start date	29 August 2018
Primary completion	30 November 2021
Estimated completion	31 March 2022
Sites	2 locations across Peru

Drugs / interventions tested

• Iron biofortified potato
• Zinc biofortified potato

Conditions studied

• Biofortification — all drugs for Biofortification →
• Potato — all drugs for Potato →

Sponsor

Instituto de Investigacion Nutricional, Peru

Who can join

Adults 18 to 45, female only, with Biofortification or Potato. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Burgos G, Liria R, Zeder C, Kroon PA, et al · · 2023 · cited 4× · PMID 37059395 · DOI 10.1016/j.tjnut.2023.04.010
2. 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.
   Liria-Domínguez R, Penny M, Kroon PA, Burgos G, et al · · 2023 · cited 2× · PMID 37648112 · DOI 10.1016/j.tjnut.2023.08.028