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Evaluation of Human Zinc Absorption From Wheat-based Meals

This study is not yet open for participant recruitment.
Verified January 2013 by Swiss Federal Institute of Technology
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01775319
First received: January 22, 2013
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates.

Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.


Condition Intervention
Zinc Deficiency
 Dietary Supplement: Biofortified wheat
Dietary Supplement: Fortified wheat
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Evaluation of Human Zinc Absorption From Wheat-based Meals

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

Primary Outcome Measures:
  • Fractional zinc absorption from different wheat-based test meals [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique.


Secondary Outcome Measures:
  • Zn and C-reactive protein concentration in plasma [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Creatinin [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biofortified wheat
Biofortified wheat
 Dietary Supplement: Biofortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Other Name: Esperia
Placebo Comparator: Control wheat
Control wheat with low level of Zn
 Dietary Supplement: Placebo
Active Comparator: Fortified wheat
Wheat fortified before consumption
 Dietary Supplement: Fortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Detailed Description:

The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The studies will be conducted with products based on wheat with high extraction rate (study part 1) and medium extraction rate (study part 2) in two separate groups of women of childbearing age.

The goal of study part 3 is to investigate the difference of absorption measurements between intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3 test meals.

  Eligibility

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

Inclusion Criteria:

  • Female, 18 to 45 years old (Study part 1 and 2). Female or male, 18 to 45 years old (Study part 3)
  • Body Mass Index in the range of 18.5 to 25 kg/m2
  • Signed informed consent

Exclusion Criteria:

  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, anemia, hepatitis, hypertension, cancer or cardiovascular diseases (according to the subjects own statement)
  • Gluten intolerance, celiac disease
  • Continuous/long-term use of medication during the whole study (except for contraceptives)
  • Vegans
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test meal administration
  • Smoking
  • Pregnancy (Urine pregnancy test shall be performed before each test meal administration)
  • Lactating
  • Earlier participation in a study using Zn stable isotopes or participation in any other clinical study within the last 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775319

Contacts
Contact: Coralie Signorell, Ing 0041446329341 coralie.signorell@hest.ethz.ch
Contact: Diego Moretti, PhD 0041 44 632 84 36 diego.moretti@hest.ethz.ch

Sponsors and Collaborators
Swiss Federal Institute of Technology
HarvestPlus
Investigators
Principal Investigator: Diego Moretti, PhD Swiss Federal Institute of Technology
  More Information

Additional Information:
Human Nutrition Laboratory website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01775319     History of Changes
Other Study ID Numbers: HNL/CTC_Zn_wheat, KEK-ZH-2012-0483
Study First Received: January 22, 2013
Last Updated: January 24, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
Zinc

ClinicalTrials.gov processed this record on May 16, 2013