NCT03019393

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 10, 2017

Last Update Submit

January 11, 2017

Conditions

Healthy

Keywords

non-transferrin bound iron (NTBI)Red meatNon-transferrin bound iron (NTBI) in serum

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Beef

OTHER

Beef topside fully cooked, 200g

Other: Beef

Interventions

BeefOTHER

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

Beef

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy male volunteers (21 - 45 years old)
  • C-reactive protein (CRP) \< 5 mg/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore; National University Hospital

Singapore, Singapore

Location

Related Publications (5)

  • 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.

    PMID: 11269606BACKGROUND

  • 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.

    PMID: 619599BACKGROUND

  • 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.

    PMID: 15629195BACKGROUND

  • 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.

    PMID: 15530152BACKGROUND

  • 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.

    PMID: 22398912BACKGROUND

MeSH Terms

Interventions

Red Meat

Intervention Hierarchy (Ancestors)

MeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Thomas Walczyk, Ph.D

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

May 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)