Glycoprotein Matrix-Bound Iron Improves Iron Absorption

Not Applicable

Completed

• Conditions: Evaluation of Bioavailability of Supplemental Forms of Iron

• Registration Number: NCT06738199
• Lead Sponsor: University of Mary Hardin-Baylor

Brief 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.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
plasma iron levels	8 hour absorption period.	Blood levels were assessed to determine if absorption rates were different between the 3 arms (forms of iron). Blood samples were taken at 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420-, and 480-minutes post-ingestion.

Trial Locations

Locations (1)

Human Performance Lab; 🇺🇸 Belton, Texas, United States