Zinc Absorption From Biofortified Rice

Healthy Clinical Trial

Official title:

Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633450
• Other study ID #: HNL/CTC12-Reis
• Status: Completed
• Phase: N/A
• First received: June 29, 2012
• Last updated: June 6, 2013
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or female of 18 to 45 years old

• Body Mass Index in the range of 19 to 25

• No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

• Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)

• Long-term medication during the whole study (except for contraceptives)

• Pregnancy

• Lactation

• Intention to become pregnant during the course of the study

• Lack of safe contraception

• Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Zinc biofortified rice
1.12 mg zinc per meal
• Rice extrinsically fortified with zinc
1.12 mg zinc per meal

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional absorption of zinc	Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.	33 days	No