Evaluation of Human Zinc Absorption From Wheat-based Meals

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
HarvestPlus
COST
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 29, 2014
Last verified: January 2014
  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 ]

Enrollment: 54
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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
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: NCT01775319

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

Additional Information:
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 29, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
Zinc

ClinicalTrials.gov processed this record on August 20, 2014