search
Back to results

Central and Peripheral Adiposity and Iron Absorption

Primary Purpose

Adiposity, Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Stable iron isotopes
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adiposity

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • either normal-weight (BMI 18-25kg/m2) or overweight/obese (BMI 28-50kg/m2) with either central or peripheral fat deposits based on DEXA

Exclusion Criteria:

  • 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.

Sites / Locations

  • American University of Beirut

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

normal-weight

peripheral adiposity

central adiposity

Arm Description

Outcomes

Primary Outcome Measures

Fractional and total iron absorption

Secondary Outcome Measures

Serum Hepcidin
Serum ferritin
iron status
Serum TfR
iron status
Serum CRP
inflammation status
Serum AGP
inflammation status
Serum IL-6
inflammation status

Full Information

First Posted
July 24, 2018
Last Updated
March 27, 2019
Sponsor
Swiss Federal Institute of Technology
Collaborators
American University of Beirut Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03642223
Brief Title
Central and Peripheral Adiposity and Iron Absorption
Official Title
Relation Btw Adiposity, Inflammation & Iron Absorption:Comparison Btw Central & Peripheral Adiposity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adiposity, Iron-deficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal-weight
Arm Type
Active Comparator
Arm Title
peripheral adiposity
Arm Type
Experimental
Arm Title
central adiposity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Stable iron isotopes
Intervention Description
Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption
Primary Outcome Measure Information:
Title
Fractional and total iron absorption
Time Frame
14days after the administration of the test meal
Secondary Outcome Measure Information:
Title
Serum Hepcidin
Time Frame
at baseline
Title
Serum ferritin
Description
iron status
Time Frame
at baseline
Title
Serum TfR
Description
iron status
Time Frame
at baseline
Title
Serum CRP
Description
inflammation status
Time Frame
at baseline
Title
Serum AGP
Description
inflammation status
Time Frame
at baseline
Title
Serum IL-6
Description
inflammation status
Time Frame
at baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: either normal-weight (BMI 18-25kg/m2) or overweight/obese (BMI 28-50kg/m2) with either central or peripheral fat deposits based on DEXA Exclusion Criteria: 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.
Facility Information:
Facility Name
American University of Beirut
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34857214
Citation
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.
Results Reference
derived

Learn more about this trial

Central and Peripheral Adiposity and Iron Absorption

We'll reach out to this number within 24 hrs