Mechanism of Decreased Iron Absorption in Obesity: Controlling Adiposity-related Inflammation

NCT02745925 | Completed

• 1 other identifier: Fe_Abs_Ibu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main iron regulatory protein in the human metabolism is hepcidin. In normal weight, healthy subjects, hepcidin is regulated through the iron status of the body: low iron status results in low hepcidin concentrations, which facilitates dietary iron absorption. In obesity, which is an inflammatory state, hepcidin concentrations are increased and iron absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether lowering the chronic low-grade inflammation during a limited treatment period and thereby lowering hepcidin concentration can improve iron absorption is uncertain.

Conditions

Obesity

Keywords

Iron bioavailability; Inflammation; Hepcidin; Iron absorption

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  The fractional iron absorption from four test meals will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meals. Calculation of fractional iron absorption will take into account the principles of isotope dilution and the fact that iron isotopic labels are not mono-isotopic. The investigators assumed iron incorporation into erythrocytes to be constant. Blood volume, needed for the calculation of fractional iron absorption will be estimated based on available data on blood volume estimations in obese women.

  Days 15 and 45

Secondary Outcomes (7)

• Plasma ferritin

  Days 1, 15, 30, 45

• Hemoglobin

  Days 1, 15, 30, 45

• Transferrin receptor

  Days 1, 15, 30, 45

• Hepcidin

  Days 1, 15, 30, 45

• c-reactive protein

  Days 1, 15, 30, 45

Study Arms (2)

normal-weight

EXPERIMENTAL

normal-weight women

Drug: Ibuprofen

obesity

EXPERIMENTAL

obese women

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

normal-weight; obesity

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• normal-weight (BMI18.5-24.9kg/m2) or obesity (BMI 29-40kg/m2)
• pre-menopausal
• no chronic illness and no significant medical conditions that could influence iron or inflammatory status other than obesity
• no-smoking

You may not qualify if:

• Diagnosed chronic disease or gastrointestinal disorders
• Metabolic disorders (e.g. diabetes)
• Regular use of medication (except oral contraceptives)
• Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
• Pregnancy or lactation

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Monterrey, Mexico: collaborator

Study Sites (1)

Human Nutrition Laboratory ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Obesity; Inflammation

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Isabelle Herter-Aeberli, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

CH (1)