- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019393
Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)
January 11, 2017 updated by: Thomas Walczyk
This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin bound iron (NTBI)
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore
- National University of Singapore; National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Beef
Beef topside fully cooked, 200g
|
200 g beef topside which is fully cooked will be provided to participant after overnight fast.
The intervention is one time only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat
Time Frame: 2 hour post meal administration
|
Blood samples collected 2 h after consumption of red meat will be analyzed for non-transferrin bound iron (NTBI) concentration
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2 hour post meal administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Walczyk, Ph.D, National University, Singapore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
March 1, 2017
Study Registration Dates
First Submitted
January 10, 2017
First Submitted That Met QC Criteria
January 11, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 13-441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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