HealthyNCT03019393
Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)
A study testing Beef in people with Healthy, run by Thomas Walczyk at 1 site in Singapore.
Trial summary
This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin bound iron (NTBI) Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Beef
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- May 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy male volunteers (21 - 45 years old)
- C-reactive protein (CRP) < 5 mg/L
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University of Singapore; National University Hospital
Singapore
About this study
This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin bound iron (NTBI)
Read the 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.
- Conditions
- Healthy
- Being tested
- Beef
- Keywords
- non-transferrin bound iron (NTBI), Red meat, Non-transferrin bound iron (NTBI) in serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeefOther
200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.
| Study group | Role | What they receive |
|---|---|---|
| Beef | Other | Beef topside fully cooked, 200g Receives: Other: Beef |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hour post meal administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Walczyk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Walczyk, National University of Singapore
- Investigators
- Thomas Walczyk, Ph.D, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019393
- Sponsor's protocol ID
- 13-441
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 11269606Monsen 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.
PubMed 619599Papanikolaou 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.
PubMed 15629195Hutchinson 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.
PubMed 15530152Schumann 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.
PubMed 22398912
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)
- ClinicalTrials.gov ID
- NCT03019393
- Acronym / sponsor ID
- 13-441
- Conditions
- Healthy
- Keywords
- non-transferrin bound iron (NTBI), Red meat, Non-transferrin bound iron (NTBI) in serum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Thomas WalczykUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beef | Other | Other: BeefBeef topside fully cooked, 200g |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Apparently healthy male volunteers (21 - 45 years old)
- C-reactive protein (CRP) < 5 mg/L
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beef200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only. | Other | Beef |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 11269606Trumbo 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.
- Background: PubMed 619599Monsen 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.
- Background: PubMed 15629195Papanikolaou 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.
- Background: PubMed 15530152Hutchinson 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.
- Background: PubMed 22398912Schumann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Walczyk, Ph.D principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beef in people with Healthy, run by Thomas Walczyk at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat (time frame: 2 hour post meal administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.