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Glycoprotein Matrix-Bound Iron Improves Iron Absorption

NCT ID: NCT06738199

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-04-22

Brief Summary

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A double-blind, randomized crossover study was conducted that evaluated absorption kinetics of 3 forms of dietary supplement iron by measuring iron levels in the blood after acute ingestion.

Detailed Description

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Background: The biotransformation of minerals through glycosylation by microorganisms, such as yeast or probiotics, can produce nutrients bound to a food matrix, potentially enhancing their bioavailability. This study aimed to compare the absorption kinetics of iron bound to a glycoprotein matrix (GPM) with those of ferrous bisglycinate chelate (FBC) and ferrous fumarate (FF). Methods: In a double-blind, crossover design, 17 participants ingested 11 mg of iron in one of three forms: GPM (Pharmachem Innovation, Kearny, NJ, USA), FBC (Ferrochel®, Balchem Corp., Montvale, NJ, USA), or FF (FerroPharma Chemicals Ltd, Hungary). Blood samples were collected at baseline and at 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420-, and 480-minutes post-ingestion. Water intake was standardized throughout the protocol, and an iron-free snack was provided at 4 hours post-ingestion. Pharmacokinetic analysis was performed, with key outcome variables including the area under the concentration vs. time curve (iAUC), maximum concentration (Cmax), and time to maximum concentration (Tmax). The a priori significance level was set at p \< 0.05.

Conditions

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Evaluation of Bioavailability of Supplemental Forms of Iron

Keywords

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Bioavailability iron absorption postbiotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
lab staff that did the analysis and lead author that performed statistical analyses

Study Groups

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glycoprotein matrix iron

Acute glycoprotein matrix iron was ingested to assess blood appearance levels from pre and at 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420-, and 480-minutes post-ingestion.

Group Type EXPERIMENTAL

dietary iron supplementation

Intervention Type DIETARY_SUPPLEMENT

This study aimed to compare the absorption kinetics of iron bound to a glycoprotein matrix (GPM) with those of ferrous bisglycinate chelate (FBC) and ferrous fumarate (FF).

ferrous bisglycinate chelate iron

Acute ferrous bisglycinate chelate iron was ingested to assess blood appearance levels from pre and at 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420-, and 480-minutes post-ingestion.

Group Type EXPERIMENTAL

dietary iron supplementation

Intervention Type DIETARY_SUPPLEMENT

This study aimed to compare the absorption kinetics of iron bound to a glycoprotein matrix (GPM) with those of ferrous bisglycinate chelate (FBC) and ferrous fumarate (FF).

ferrous fumarate iron

Acute ferrous fumarate iron was ingested to assess blood appearance levels from pre and at 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420-, and 480-minutes post-ingestion.

Group Type EXPERIMENTAL

dietary iron supplementation

Intervention Type DIETARY_SUPPLEMENT

This study aimed to compare the absorption kinetics of iron bound to a glycoprotein matrix (GPM) with those of ferrous bisglycinate chelate (FBC) and ferrous fumarate (FF).

Interventions

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dietary iron supplementation

This study aimed to compare the absorption kinetics of iron bound to a glycoprotein matrix (GPM) with those of ferrous bisglycinate chelate (FBC) and ferrous fumarate (FF).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Participants had to have a normal body weight \[body mass index (BMI) of 19-24.99 kg/m2\] and engage in recreational physical activity, as defined by the American College of Sports Medicine guidelines.
* Participants must be healthy and have no diagnosed chronic disease conditions

Exclusion Criteria

* Participants were not allowed to consume any nutritional supplements known to affect the measures of the current study for at least 6 weeks prior to participation, including pro-, post- and prebiotics, as well as digestive enzymes.
* Individuals who were currently being treated for or diagnosed with a gastrointestinal, cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder.
* Participants whose body mass had deviated by more than 2% in the previous 30 days
* Participants who were unwilling to abstain from alcohol, nicotine, and caffeine for 12 hours prior to each visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharmachem Innovations

UNKNOWN

Sponsor Role collaborator

University of Mary Hardin-Baylor

OTHER

Sponsor Role lead

Responsible Party

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Lemuel W. Taylor IV

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Human Performance Lab

Belton, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GPMiron

Identifier Type: -

Identifier Source: org_study_id