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Completed

NCT Number: NCT01775319

Evaluation of Human Zinc Absorption From Wheat-based Meals

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofortified wheat

Dietary Supplement

Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Other names: Esperia

Fortified wheat

Dietary Supplement

Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose

Placebo

Dietary Supplement

Primary outcomes

  1. Fractional zinc absorption from different wheat-based test meals

    Time frame: 3 months

    Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique.

Secondary outcomes

  1. Zn and C-reactive protein concentration in plasma

    Time frame: 3 months

Other outcomes

  1. Creatinin

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • HarvestPlus

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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