Evaluation of the Effect of Body Weight and Composition on Iron Absorption and Blood Volume

NCT01884506 | Completed DMC

• 1 other identifier: KEKZH-2013-0110
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 75 subjects will be recruited for this study (25 normal weight, 25 overweight, 25 obese). In each subject blood volume will be determined using the minimally invasive carbon monoxide-rebreathing method (substudy 1) and iron absorption will be measured from a test meal labeled with stable iron isotopes. The effect of ascorbic acid on iron absorption will further be determined using a second labeled test meal (substudy 2). In addition, inflammation, hepcidin and iron status will be determined. In order to study the effect of body fat content on blood volume and iron absorption weight and height will be measured, and body fat will de determined by dual energy X-ray absorptiometry.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption from the isotopically labeled test meals.

  Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of the last test meal containing labeled iron (stable isotope technique). Based on the shift of the iron isotope ratios in the blood samples and the amount of iron circulating in the body, the amounts of isotopic label iron present in the blood 14 days after the test meal administration will be calculated based on the principles of isotope dilution and considering that the iron isotopic labels are not monoisotopic. Circulating iron will be calculated based on blood volume as determined by carbon monoxide-rebreathing. For calculation of fractional absorption, 80% incorporation of the absorbed iron into red blood cells will be assumed.

  Baseline

Secondary Outcomes (1)

• Hemoglobin mass will be measured with the carbon monoxide-rebreathing method.

  Baseline

Study Arms (2)

labeled iron meal

EXPERIMENTAL

Test meal (bread with honey) with a labeled iron solution

Dietary Supplement: labeled iron solution; Dietary Supplement: labeled iron solution and ascorbic acid

labeled iron and ascorbic acid meal

EXPERIMENTAL

Test meal (bread with honey) with a labeled iron solution and ascorbic acid

Dietary Supplement: labeled iron solution; Dietary Supplement: labeled iron solution and ascorbic acid

Interventions

labeled iron solution DIETARY_SUPPLEMENT

labeled iron as ferrous sulfate (6mg/test meal)

labeled iron and ascorbic acid meal; labeled iron meal

labeled iron solution and ascorbic acid DIETARY_SUPPLEMENT

labeled iron as ferrous sulfate plus ascorbic acid (6mg:30mg /test meal)

labeled iron and ascorbic acid meal; labeled iron meal

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Age 18-45 years
• Pre-menopausal (no absence of a menstrual cycle in the past 12 months)
• BMI 18.5-39.9 kg/m2 (n=25 18.5-24.9, n=25 25-29.9, n=25 30-39.9)
• Apparently healthy (no significant medical conditions that could influence iron or inflammatory status other than obesity (i.e., cancer, HIV/AIDS, inflammatory bowel disease, gastrointestinal bleeding, and rheumatoid arthritis, renal disease or hemochromatosis) (judged by study physician)

You may not qualify if:

• Moderate/sever anemia (Hb\<11 g/dl)
• Use of medication which interferes with study measurements (judged by the study physician)
• Smoking
• Pregnancy and lactation; planning to become pregnant during the course of the study (pregnancy test will be conducted at visit 2 and subjects will be asked about contraception\*)
• Consumption of vitamin- or mineral supplements unless they consent to discontinue intake two weeks before the start of the study until the final blood sampling
• Prior participation in studies using stable iron isotopes
• Food allergies/intolerances (gluten, lactose, milk protein)
• Blood donation during the two months prior to the study
• Major injuries during the 6 months prior to the study
• Illness during the 4 weeks prior to the study (judged by study physician)
• Administration of recombinant erythropoietin (rhEPO)
• More than 5 days at altitudes above 1600 m above sea level during the 3 weeks prior to the study
• Long distance flight (\>8 h) during the 3 weeks prior to the study
• Chronic alcohol abuse

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Wageningen University: collaborator
• Universidad de Monterrey: collaborator

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

• Cepeda-Lopez AC, Melse-Boonstra A, Zimmermann MB, Herter-Aeberli I. In overweight and obese women, dietary iron absorption is reduced and the enhancement of iron absorption by ascorbic acid is one-half that in normal-weight women. Am J Clin Nutr. 2015 Dec;102(6):1389-97. doi: 10.3945/ajcn.114.099218. Epub 2015 Nov 11.

  PMID: 26561622 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Isabelle Aeberli, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 24, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

CH (1)