Evaluation of Human Zinc Absorption From Wheat-based Meals

NCT01775319 | Completed

• 2 other identifiers: HNL/CTC_Zn_wheatKEK-ZH-2012-0483
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Zinc Deficiency

Keywords

Zinc

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Zn and C-reactive protein concentration in plasma

  3 months

Other Outcomes (1)

• Creatinin

  2 months

Study Arms (3)

Biofortified wheat

ACTIVE COMPARATOR

Biofortified wheat

Dietary Supplement: Biofortified wheat

Control wheat

PLACEBO COMPARATOR

Control wheat with low level of Zn

Dietary Supplement: Placebo

Fortified wheat

ACTIVE COMPARATOR

Wheat fortified before consumption

Dietary Supplement: Fortified wheat

Interventions

Biofortified wheat DIETARY_SUPPLEMENT

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

Also known as: Esperia

Biofortified wheat

Fortified wheat DIETARY_SUPPLEMENT

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

Fortified wheat

Placebo DIETARY_SUPPLEMENT

Control wheat

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• HarvestPlus: collaborator

Related Publications (1)

• Signorell C, Zimmermann MB, Cakmak I, Wegmuller R, Zeder C, Hurrell R, Aciksoz SB, Boy E, Tay F, Frossard E, Moretti D. Zinc Absorption From Agronomically Biofortified Wheat Is Similar to Post-Harvest Fortified Wheat and Is a Substantial Source of Bioavailable Zinc in Humans. J Nutr. 2019 May 1;149(5):840-846. doi: 10.1093/jn/nxy328.

  PMID: 31004128 DERIVED

Study Officials

• Diego Moretti, PhD

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 14, 2016

Record last verified: 2016-04