Evaluation of Human Zinc Absorption From Wheat-based Meals

Zinc Deficiency Clinical Trial

Official title:

Evaluation of Human Zinc Absorption From Wheat-based Meals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775319
• Other study ID #: HNL/CTC_Zn_wheat
• Secondary ID: KEK-ZH-2012-0483
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: April 13, 2016
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2016
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Dietary Supplement:
• Biofortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
• Fortified wheat
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	HarvestPlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Creatinin		2 months	No
Primary	Fractional zinc absorption from different wheat-based test meals	Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique.	3 months	No
Secondary	Zn and C-reactive protein concentration in plasma		3 months	No

External Links

•   Human Nutrition Laboratory website