Clinical Trials Directory

Trials / Completed

CompletedNCT06738199

Glycoprotein Matrix-Bound Iron Improves Iron Absorption

Glycoprotein Matrix-Bound Iron Improves Absorption Compared to Ferrous Bisglycinate Chelate and Ferrous Fumarate: a Randomized Crossover Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
17 (actual)
Sponsor
University of Mary Hardin-Baylor · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

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

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTdietary iron supplementationThis 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).

Timeline

Start date
2024-02-01
Primary completion
2024-04-22
Completion
2024-04-22
First posted
2024-12-17
Last updated
2024-12-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06738199. Inclusion in this directory is not an endorsement.