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Completed

NCT Number: NCT06738199

Glycoprotein Matrix-Bound Iron Improves Iron Absorption

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Performance Lab

Belton, Texas, 76513, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dietary iron supplementation

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).

Primary outcomes

  1. plasma iron levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Mary Hardin-Baylor

Other

Collaborators

  • Pharmachem Innovations

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.