Central and Peripheral Adiposity and Iron Absorption

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642223
• Other study ID #: FLAB
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: October 18, 2018

Study information

• Verified date: March 2019
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adiposity
• Anemia, Iron-Deficiency
• Iron-deficiency
• Obesity

Intervention

Other:
• Stable iron isotopes
Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional and total iron absorption		14days after the administration of the test meal
Secondary	Serum Hepcidin		at baseline
Secondary	Serum ferritin	iron status	at baseline
Secondary	Serum TfR	iron status	at baseline
Secondary	Serum CRP	inflammation status	at baseline
Secondary	Serum AGP	inflammation status	at baseline
Secondary	Serum IL-6	inflammation status	at baseline