NCT06738199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 12, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

Bioavailabilityironabsorptionpostbiotic

Outcome Measures

Primary Outcomes (1)

  • plasma iron levels

    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.

    8 hour absorption period.

Study Arms (3)

glycoprotein matrix iron

EXPERIMENTAL

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.

Dietary Supplement: dietary iron supplementation

ferrous bisglycinate chelate iron

EXPERIMENTAL

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.

Dietary Supplement: dietary iron supplementation

ferrous fumarate iron

EXPERIMENTAL

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.

Dietary Supplement: dietary iron supplementation

Interventions

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 ironferrous fumarate ironglycoprotein matrix iron

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Lab

Belton, Texas, 76513, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
lab staff that did the analysis and lead author that performed statistical analyses
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

February 1, 2024

Primary Completion

April 22, 2024

Study Completion

April 22, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Individual data is available upon reasonable request based on the data in the actual peer-reviewed paper

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
From date of possible manuscript publication and 2 years following that publication date.
Access Criteria
Research can contact the listed corresponding author in published manuscript of this data.

Locations