Central and Peripheral Adiposity and Iron Absorption
Relation Btw Adiposity, Inflammation & Iron Absorption:Comparison Btw Central & Peripheral Adiposity
1 other identifier
interventional
121
1 country
1
Brief Summary
Adiposity is a state of sub-clinical inflammation, thus hepcidin is increased in adiposity, often leading to iron deficiency in this population group. Central adiposity is generally considered having a greater negative effect on health compared to peripheral adiposity. Whether this can be also seen in hepcidin and thereby in iron absorption is uncertain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2017
CompletedFirst Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2018
CompletedMarch 28, 2019
March 1, 2019
1.1 years
July 24, 2018
March 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Fractional and total iron absorption
14days after the administration of the test meal
Secondary Outcomes (6)
Serum Hepcidin
at baseline
Serum ferritin
at baseline
Serum TfR
at baseline
Serum CRP
at baseline
Serum AGP
at baseline
- +1 more secondary outcomes
Study Arms (3)
normal-weight
ACTIVE COMPARATORperipheral adiposity
EXPERIMENTALcentral adiposity
EXPERIMENTALInterventions
Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption
Eligibility Criteria
You may qualify if:
- either normal-weight (BMI 18-25kg/m2) or overweight/obese (BMI 28-50kg/m2) with either central or peripheral fat deposits based on DEXA
You may not qualify if:
- Iron Supplement or antibiotic intake within 2 weeks before study start
- diagnosed chronic disease or gastrointestinal disorders
- regular use of medication (except contraceptives)
- pregnancy
- lactation
- smoking
- blood donation or surgery within the last 4 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut
Beirut, Lebanon
Related Publications (1)
El-Helou N, El-Mallah C, Wehbe N, Bissani N, Stoffel N, Herter-Aeberli I, Zimmermann M, Obeid O. A test to measure oral iron absorption and glucose tolerance simultaneously in 18 to 55 year old premenopausal women. Clin Nutr ESPEN. 2021 Dec;46:325-329. doi: 10.1016/j.clnesp.2021.09.737. Epub 2021 Sep 29.
PMID: 34857214DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
July 24, 2018
First Posted
August 22, 2018
Study Start
September 10, 2017
Primary Completion
October 18, 2018
Study Completion
October 18, 2018
Last Updated
March 28, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share