Clinical trial NCT03019393: Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)
Official title: Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: non-transferrin bound iron (NTBI)
Red meat
Non-transferrin bound iron (NTBI) in serum
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat
timeFrame: 2 hour post meal administration
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore; National University Hospital
Study officials:
affiliation: National University of Singapore
name: Thomas Walczyk, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.
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. doi: 10.1093/ajcn/31.1.134.
citation: Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. doi: 10.1016/j.taap.2004.06.021.
citation: 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. doi: 10.1111/j.1365-2362.2004.01416.x. No abstract available.
citation: Schumann 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. Epub 2012 Mar 6.