The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women

NCT05233709 | Completed

• 1 other identifier: OTf
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism. Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants \[19\]. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women. OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  The primary outcome is iron bioavailability (as measured by erythrocyte incorporation of the stable isotope labels) from the 2 different conditions in the standardized test meals.

  Day 19th of the study

Secondary Outcomes (4)

• Hemoglobin (Hb)

  Screening (-14,) day 1 and day 19th

• Serum ferritin (SF)

  Screening (-14,) day 1 and day 19th

• Serum transferrin receptor (sTfR),

  Screening (-14,) day 1 and day 19th

• C-reactive protein (CRP)

  Screening (-14,) day 1 and day 19th

Study Arms (3)

OTf + FeSO4

OTHER

OTf + FeSO4 - This is the experimental arm where Ferrous sulfate will be given to the participants along with apo-Ovotransferrin, a potential iron absorption enhancer. They will be given as solutions that will be spread on bread with butter and honey, a breakfast meal.

Dietary Supplement: FeSO4 + OTf

Lf+ FeSO4

OTHER

Lf + FeSO4 - This is the experimental arm where Ferrous sulfate will be given to the participants along with lactoferrin, a potential iron absorption enhancer. They will be given as solutions that will be spread on bread with butter and honey, a breakfast meal.

Dietary Supplement: FeSO4 + Lf

FeSO4

OTHER

FeSO4 - This is the control arm where Ferrous sulfate will be given in the form of a solution that will be spread on bread with butter and honey, as a breakfast meal

Dietary Supplement: FeSO4

Interventions

FeSO4 + OTf DIETARY_SUPPLEMENT

OTf (apo ovotransferrin) + FeSO4

OTf + FeSO4

FeSO4 + Lf DIETARY_SUPPLEMENT

Lf (lactoferrin) + FeSO4

Lf+ FeSO4

FeSO4 DIETARY_SUPPLEMENT

Ferrous sulfate

FeSO4

Eligibility Criteria

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

You may qualify if:

• female aged between 18-45 years old;
• SF \<25 µg / L;
• BMI 18.5-24.9 kg / m2;
• weight \<70 kg;
• signed informed consent;
• Able to communicate and comprehend English language.

You may not qualify if:

• Anemic (Hb \<12 g / dL);
• inflammation (CRP\> 5 mg / L);
• chronic digestive, renal and / or metabolic disease;
• chronic medications (except for oral contraceptives);
• use of vitamin, mineral and pre- and / or probiotic supplements in the previous 2 weeks and during the course of the study;
• blood transfusion, blood donation or significant blood loss over the past 4 months;
• difficulties with blood sampling;
• antibiotic treatment in the previous 4 weeks before the start of the study and during the course of the study;
• known hypersensitivity to egg;
• pregnancy (tested in serum at screening) or intention to become pregnant during the course of the study;
• lactation up to 6 weeks before study initiation;

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Zurich, Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica Rigutto-Farebrother, PhD

  Laboratory of Human Nutrition ETH Zürich

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: February 10, 2022
• Study Start: April 25, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)