Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)

Healthy Clinical Trial

Official title:

Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03019393
• Other study ID #: 13-441
• Status: Active, not recruiting
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 11, 2017
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin bound iron (NTBI)

Description:

During Visit 1, blood samples will be collected to assess iron status. During Visit 2, after an overnight fast, participant will be given a standardized meal (rice and potatoes) with a portion of cooked beef (200 g). Blood samples will be collected right before and 2 hour after the meal for NTBI analysis.

NTBI concentration before and after meal consumption will be compared.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Apparently healthy male volunteers (21 - 45 years old)

• C-reactive protein (CRP) < 5 mg/L

Exclusion Criteria:

• Blood donation or significant blood loss (e.g. surgery) within the past 4 months

• Regular intake of iron and other nutrient supplements within the past 4 months

• Regular intake of medication except oral contraceptives

• Acute or recent inflammatory or infectious symptoms

• Chronic gastrointestinal disorders or metabolic diseases

• Smoking

• Coeliac disease or gluten-related disorders

• Iron deficiency anemia (Hb < 14 g/dL for males) with serum ferritin concentration < 30 ng/mL)

• Non-iron deficiency anemia (serum ferritin concentration within normal range (30 - 300 ng/mL for males) but low hemoglobin (< 14 g/dL for males)

• Iron overload conditions (serum ferritin concentration > 300 ng/mL for males)

• Known hereditary disorders of iron metabolism

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Beef
200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.

Locations

Country	Name	City	State
Singapore	National University of Singapore; National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Walczyk

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

Hutchinson C, Al-Ashgar W, Liu DY, Hider RC, Powell JJ, Geissler CA. Oral ferrous sulphate leads to a marked increase in pro-oxidant nontransferrin-bound iron. Eur J Clin Invest. 2004 Nov;34(11):782-4. — View Citation

Monsen ER, Hallberg L, Layrisse M, Hegsted DM, Cook JD, Mertz W, Finch CA. Estimation of available dietary iron. Am J Clin Nutr. 1978 Jan;31(1):134-41. — View Citation

Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. Review. — View Citation

Schümann K, Kroll S, Romero-Abal ME, Georgiou NA, Marx JJ, Weiss G, Solomons NW. Impact of oral iron challenges on circulating non-transferrin-bound iron in healthy Guatemalan males. Ann Nutr Metab. 2012;60(2):98-107. doi: 10.1159/000336177. — View Citation

Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat	Blood samples collected 2 h after consumption of red meat will be analyzed for non-transferrin bound iron (NTBI) concentration	2 hour post meal administration	No