Tea Consumption and Iron Bioavailability in Women Using a Stable Isotope

NCT02365103 | Completed

• 1 other identifier: 14/NW/0310 S-LS17042014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the inhibition effect of tea consumption on non haem iron absorption with the use of an iron tracer. The study also aims to assess the effect of time variability of tea consumption on non haem iron absorption from a typical western breakfast.

Conditions

Anemia, Iron-Deficiency

Keywords

Anemia, Iron-Deficiency; Iron, Bioavailability; Hepcidins; Intestinal, Absorption; Isotope Labeling, Stable

Outcome Measures

Primary Outcomes (1)

• Iron absorption (%) measured by mass spectrometer

  Iron absorption is estimated based on the erythrocyte iron incorporation to the body system with the use of iron tracer after 14 days following administration of the test meals

  14 days after each test meal

Secondary Outcomes (8)

• Serum ferritin measured by Biomerieux mini VIDAS

  1 year

• Hepcidin measured by enzyme-linked immunosorbent assay (ELISA) kit

  1 year

• Full blood count measured by Beckman Coulter Counter

  1 year

• Zinc protoporphyrin (ZPP) measured by haemato-fluorimetry

  1 year

• Total binding iron capacity (TIBC) measured by enzyme-linked immunosorbent assay (ELISA) kit

  1 year

Study Arms (4)

Test meal I (given with water)

OTHER

Test meal with water

Other: Test meal I (given with water)

Test meal II (simultaneously with tea)

OTHER

Test meal with tea (simultaneously)

Other: Test meal II (simultaneously with tea)

Test meal III (1 hour after test meal)

OTHER

Test Meal with tea given 1 hour after test meal

Other: Test meal III (1 hour after test meal)

Reference Iron Dose

OTHER

Reference iron dose administered

Other: Reference iron dose

Interventions

Test meal I (given with water) OTHER

4 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled in the test meal administered in the study, enrichment in the system will take approximately 14 days post dosing

Test meal I (given with water)

Test meal II (simultaneously with tea) OTHER

4 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled in the test meal administered in the study, enrichment in the system will take approximately 14 days post dosing

Test meal II (simultaneously with tea)

Test meal III (1 hour after test meal) OTHER

4 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled in the test meal administered in the study, enrichment in the system will take approximately 14 days post dosing

Test meal III (1 hour after test meal)

Reference iron dose OTHER

3 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled and administered in the study, enrichment in the system will take approximately 14 days post dosing

Reference Iron Dose

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pre menopausal women;
• aged 19- 40 years;
• healthy;
• non- pregnant nor lactating.

You may not qualify if:

• history of gastrointestinal and metabolic disorders;
• have donated blood within past 6 months;
• regularly consuming nutritional supplements.

Sponsors & Collaborators

• University of Chester: lead

Study Sites (1)

University of Chester

Chester, Cheshire, CH1 4BJ, United Kingdom

Location

Related Publications (1)

• Ahmad Fuzi SF, Koller D, Bruggraber S, Pereira DI, Dainty JR, Mushtaq S. A 1-h time interval between a meal containing iron and consumption of tea attenuates the inhibitory effects on iron absorption: a controlled trial in a cohort of healthy UK women using a stable iron isotope. Am J Clin Nutr. 2017 Dec;106(6):1413-1421. doi: 10.3945/ajcn.117.161364. Epub 2017 Oct 18.

  PMID: 29046302 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Water; Tea

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sohail Mushtaq, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 18, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)