NCT03642223

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

July 24, 2018

Last Update Submit

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 COMPARATOR
Other: Stable iron isotopes

peripheral adiposity

EXPERIMENTAL
Other: Stable iron isotopes

central adiposity

EXPERIMENTAL
Other: Stable iron isotopes

Interventions

Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption

central adipositynormal-weightperipheral adiposity

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

ObesityAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic Diseases

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

Locations