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Zinc Absorption From Biofortified Rice

This study has been completed.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01633450
First received: June 29, 2012
Last updated: June 6, 2013
Last verified: June 2013
History of Changes
  Purpose
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.

Condition Intervention
Healthy
 Other: Zinc biofortified rice
Other: Rice extrinsically fortified with zinc

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study

Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Fractional absorption of zinc [ Time Frame: 33 days ] [ Designated as safety issue: No ]
    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.
Enrollment: 16
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc biofortified rice Other: Zinc biofortified rice
1.12 mg zinc per meal
Active Comparator: Rice extrinsically fortified with zinc Other: Rice extrinsically fortified with zinc
1.12 mg zinc per meal

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633450

Locations
Switzerland
ETH Zurich
Zurich, Switzerland
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of Zurich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01633450     History of Changes
Other Study ID Numbers: HNL/CTC12-Reis 
Study First Received: June 29, 2012
Last Updated: June 6, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016