Clinical trial NCT06738199: Glycoprotein Matrix-Bound Iron Improves Iron Absorption
Official title: Glycoprotein Matrix-Bound Iron Improves Absorption Compared to Ferrous Bisglycinate Chelate and Ferrous Fumarate: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of Bioavailability of Supplemental Forms of Iron
Keywords: Bioavailability
iron
absorption
postbiotic
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
Collaborators: name: Pharmachem Innovations
First posted: 2024-12-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: plasma iron levels
timeFrame: 8 hour absorption period.
Secondary outcomes:
Other outcomes:
Locations:
city: Belton
country: United States
facility: Human Performance Lab
state: Texas
Study officials:
References: