Iron Absorption From Encapsulated Iron Sulphate in Microspheres

NCT03332602 | Completed

• 1 other identifier: Omnifortificant
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes. Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.

Conditions

Iron-deficiency

Keywords

Iron deficiency; Iron fortification; Iron encapsulation

Outcome Measures

Primary Outcomes (3)

• Change from baseline in the isotopic ratio of iron in blood at week 2

  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  baseline, 2 weeks

• Change from week 2 in the isotopic ratio of iron in blood at week 4

  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  2 weeks, 4 weeks

• Change from week 4 in the isotopic ratio of iron in blood at week 6

  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  4 weeks, 6 weeks

Secondary Outcomes (3)

• Haemoglobin

  baseline, weeks 2, 4 and 6

• Plasma Ferritin

  baseline, weeks 2, 4 and 6

• inflammation marker

  baseline, weeks 2, 4 and 6

Study Arms (9)

free FeSO4

EXPERIMENTAL

wheat bread fortified with free FeSO4

Dietary Supplement: free FeSO4

free FeSO4 and empty microspheres

EXPERIMENTAL

wheat bread fortified with free FeSO4, and empty microspheres

Dietary Supplement: free FeSO4 and empty microspheres

free FeSO4 with eudragit polymer

EXPERIMENTAL

wheat bread fortified with free FeSO4, and eudragit polymer

Dietary Supplement: free FeSO4 and eudragit polymer

free FeSO4 with Hyaluronic Acid

EXPERIMENTAL

wheat bread fortified with free FeSO4, and hyaluronic acid

Dietary Supplement: free FeSO4 and hylauronic acid

encapsulated FeSO4 3.2%

EXPERIMENTAL

wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading

Dietary Supplement: encapsulated FeSO4 3.2%

encapsulated FeSO4 20%

EXPERIMENTAL

wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading

Dietary Supplement: encapsulated FeSO4 20%

encapsulated FeSO4 3.2%, encap. Vitamin A

EXPERIMENTAL

wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres

Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A

encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid

EXPERIMENTAL

wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid

Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid

FeSO4 embedded in Hyaluronic Acid

EXPERIMENTAL

wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.

Dietary Supplement: FeSO4 embedded in Hyaluronic acid

Interventions

free FeSO4 DIETARY_SUPPLEMENT

Testmeal with free FeSO4

free FeSO4

free FeSO4 and empty microspheres DIETARY_SUPPLEMENT

Testmeal with free FeSO4 and empty micropsheres

free FeSO4 and empty microspheres

free FeSO4 and hylauronic acid DIETARY_SUPPLEMENT

Testmeal with free FeSO4 and hyaluronic acid

free FeSO4 with Hyaluronic Acid

free FeSO4 and eudragit polymer DIETARY_SUPPLEMENT

Testmeal with free FeSO4 and eudragit polymer

free FeSO4 with eudragit polymer

encapsulated FeSO4 3.2% DIETARY_SUPPLEMENT

Testmeal with encapsulated FeSO4 with 3.2% Fe loading

encapsulated FeSO4 3.2%

encapsulated FeSO4 20% DIETARY_SUPPLEMENT

Testmeal with encapsulated FeSO4 with 20% Fe loading

encapsulated FeSO4 20%

encapsulated FeSO4 3.2%, encapsulated Vitamin A DIETARY_SUPPLEMENT

Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A

encapsulated FeSO4 3.2%, encap. Vitamin A

encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid DIETARY_SUPPLEMENT

Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.

encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid

FeSO4 embedded in Hyaluronic acid DIETARY_SUPPLEMENT

Testmeal with FeSO4 embedded in Hyaluronic acid

FeSO4 embedded in Hyaluronic Acid

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 18 to 40 years old
• Marginal iron status (PF \<25 ng/ml)
• Body weight \< 65 kg
• Normal body Mass Index (18.5 - 25 kg/m2)
• Signed informed consent

You may not qualify if:

• Pregnancy (assessed by a pregnancy test) / intention to become pregnant
• Lactating up to 6 weeks before study initiation
• Moderate or severe anaemia (Hb \< 9.0 g/dL)
• Elevated C reactive Protein (CRP) (\> 5.0 mg/L)
• Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, 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 meal administration
• Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
• Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
• Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

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: October 18, 2017
• First Posted: November 6, 2017
• Study Start: April 4, 2018
• Primary Completion: July 18, 2018
• Study Completion: August 20, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

CH (1)