Evaluating Iron and Zinc Bioavailability From Biofortified Potatoes to Reduce Malnutrition in the Andean Highlands

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

• 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.

Locations
Other Locations
Peru
International Potato Center
Recruiting
Lima
Research Nutritional Institute
Recruiting
Lima
Contact Information
Primary
Reyna Liria-Dominguez, PhD
rliria@iin.sld.pe
+511 3496023
Backup
Gabriela Burgos, PhD
G.BURGOS@cgiar.org
+511 3496017
Time Frame
Start Date: August 29, 2018
Estimated Completion Date: March 31, 2022
Participants
Target number of participants: 70
Treatments
Experimental: Biofortified Potato with iron or zinc ('A')
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.
Placebo Comparator: Non Biofortified potato with iron or zinc ('B')
Women volunteers will consume no biofortified ('B') for one day in zinc study, and 10 days in iron study
Authors
Reyna Liria-Domínguez
Related Therapeutic Areas
Sponsors
Collaborators: Quadram Institute Bioscience, University of East Anglia
Leads: Instituto de Investigacion Nutricional, Peru

This content was sourced from clinicaltrials.gov

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