Central and Peripheral Adiposity and Iron Absorption

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03642223
• Collaborator: American University of Beirut Medical Center (Other)
• Enrollment: 121
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 9.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adiposity; Iron-deficiency	Other: Stable iron isotopes	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Relation Btw Adiposity, Inflammation & Iron Absorption:Comparison Btw Central & Peripheral Adiposity
• Actual Study Start Date: Sep 10, 2017
• Actual Primary Completion Date: Oct 18, 2018
• Actual Study Completion Date: Oct 18, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fractional and total iron absorption [14days after the administration of the test meal]

Secondary Outcome Measures

1. Serum Hepcidin [at baseline]

2. Serum ferritin [at baseline]

   iron status

3. Serum TfR [at baseline]

   iron status

4. Serum CRP [at baseline]

   inflammation status

5. Serum AGP [at baseline]

   inflammation status

6. Serum IL-6 [at baseline]

   inflammation status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American University of Beirut	Beirut		Lebanon

Sponsors and Collaborators

• Swiss Federal Institute of Technology
• American University of Beirut Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med., Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT03642223
• Other Study ID Numbers: FLAB
• First Posted: Aug 22, 2018
• Last Update Posted: Mar 28, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Mar 28, 2019