Central and Peripheral Adiposity and Iron Absorption

March 27, 2019 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Relation Btw Adiposity, Inflammation & Iron Absorption:Comparison Btw Central & Peripheral Adiposity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

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

  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: normal-weight
Other: Stable iron isotopes
Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption
Experimental: peripheral adiposity
Other: Stable iron isotopes
Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption
Experimental: central adiposity
Other: Stable iron isotopes
Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fractional and total iron absorption
Time Frame: 14days after the administration of the test meal
14days after the administration of the test meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Hepcidin
Time Frame: at baseline
at baseline
Serum ferritin
Time Frame: at baseline
iron status
at baseline
Serum TfR
Time Frame: at baseline
iron status
at baseline
Serum CRP
Time Frame: at baseline
inflammation status
at baseline
Serum AGP
Time Frame: at baseline
inflammation status
at baseline
Serum IL-6
Time Frame: at baseline
inflammation status
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

American University of Beirut Medical Center

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

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 (Actual)

September 10, 2017

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

October 18, 2018

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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