The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements

NCT04194255 | Completed

• 1 other identifier: HIGH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency (ID) remains the most common global nutrient deficiency, with young women at high risk. Iron supplements are first line treatment for ID but absorption is often low. Dietary components that could increase iron absorption would be valuable. Prebiotics are among the potential enhancers of non-heme iron absorption. Galacto-oligosaccharides (GOS), fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics. To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%). For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia. If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.

Conditions

Iron-deficiency

Keywords

iron-deficiency; Prebiotics; galacto-oligosaccharides; fructo-oligosaccharides; acacia gum

Outcome Measures

Primary Outcomes (1)

• fractional iron absorption

  Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

  43 days

Secondary Outcomes (7)

• Hemoglobin (Hb)

  Baseline, 43 days

• Serum ferritin

  Baseline, 43 days

• soluble transferrin receptor

  Baseline, 43 days

• serum iron

  Baseline, 43 days

• alpha-1-acid glycoprotein (AGP)

  Baseline, 43 days

Study Arms (4)

ferrous fumarate

EXPERIMENTAL

labelled iron as ferrous fumarate

Dietary Supplement: ferrous fumarate

ferrous fumarate + 15 g GOS

EXPERIMENTAL

labelled iron as ferrous fumarate + prebiotics in the form of 15 g GOS

Dietary Supplement: ferrous fumarate + 15 g GOS

ferrous fumarate + 15 g FOS

EXPERIMENTAL

labelled iron as ferrous fumarate + prebiotics in the form of 15 g FOS

Dietary Supplement: ferrous fumarate + 15 g FOS

ferrous fumarate + 15 g acacia gum

EXPERIMENTAL

labelled iron as ferrous fumarate + prebiotics in the form of 15 g acacia gum

Dietary Supplement: labelled iron as ferrous fumarate + 15 g acacia gum

Interventions

ferrous fumarate DIETARY_SUPPLEMENT

iron (100 mg) supplement in form of ferrous fumarate

ferrous fumarate

ferrous fumarate + 15 g GOS DIETARY_SUPPLEMENT

iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)

ferrous fumarate + 15 g GOS

ferrous fumarate + 15 g FOS DIETARY_SUPPLEMENT

iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g FOS)

ferrous fumarate + 15 g FOS

labelled iron as ferrous fumarate + 15 g acacia gum DIETARY_SUPPLEMENT

iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g acacia gum)

ferrous fumarate + 15 g acacia gum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only female participants are being studied
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 18 to 45 years old
• SF concentrations ≤ 25 µg/L
• Normal body Mass Index (18.5-24.9 kg/m2)
• Body weight \<70 kg
• Signed informed consent

You may not qualify if:

• Anaemia (Hb \< 11,7g/dL)
• Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
• Continuous/long-term use of medication during the whole study (except for contraceptives),
• Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and/or probiotic supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
• Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
• Known difficulties with blood sampling
• Use of antibiotics over the past month
• Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
• Women who are pregnant or breast feeding
• Women who intend to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
• Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse
• Smokers (\> 1 cigarette per week)
• Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

• Giorgetti A, Husmann FMD, Zeder C, Herter-Aeberli I, Zimmermann MB. Prebiotic Galacto-Oligosaccharides and Fructo-Oligosaccharides, but Not Acacia Gum, Increase Iron Absorption from a Single High-Dose Ferrous Fumarate Supplement in Iron-Depleted Women. J Nutr. 2022 Apr 1;152(4):1015-1021. doi: 10.1093/jn/nxac003.

  PMID: 35015879 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous fumarate; Gum Arabic

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Isabelle Herter-Aeberli, PhD

  Laboratory of Human Nutrition ETH Zürich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: July 20, 2020
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)