Modulation of hepcidIN With Co-supplementation of Iron and FORMulated Curcumin in Recreational Athletes (IN-FORM)

August 15, 2025 updated by: Mohammed Gulrez Zariwala, University of Westminster

Co-supplementation of Ferrous Iron With Formulated Curcumin Reduces Hepcidin Response in Trained Individuals: a Cross-over, Double-blinded, Placebo-controlled Human Intervention Study

Iron deficiency and iron deficiency anaemia are common among endurance athletes partly due to a repeated post-exercise elevation of hepcidin, a hormone limiting iron entry through the intestine. Oral iron supplementation also causes stimulation of hepcidin that adds on to the exercise-intrinsic stimulation of this hormone further reducing iron absorption. Both oral ferrous iron therapy and performance running are known to cause undesired gastrointestinal symptoms. Curcumin, a polyphenol from turmeric, has been previously shown to reduce hepcidin levels in resting individuals and to protect the gastrointestinal (GI) function but its effect on active individuals supplementing with iron remains unclarified.

The objective of this research study is to learn about the effects of a formulated curcumin (HydroCurc®) on intestinal health and regulation mechanisms of body iron levels in recreationally active athletes supplementing with iron.

The main questions to answer are:

Does HydroCurc® influence iron regulatory mechanisms in resting conditions? Does HydroCurc® influence iron regulatory mechanisms in post-exercise conditions? Does HydroCurc® alleviate iron supplementation- and exercise-related gastrointestinal adverse events

Researchers will compare HydroCurc® to a placebo (a look-alike substance that contains no drug) to see if there are any significant changes.

Participants will:

  • Perform a fitness test
  • Take iron and HydroCurc for seven days
  • Complete questionnaires on their gastrointestinal health
  • Complete anthropometric testing
  • Undergo blood sampling

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intervention study with two treatment groups in a randomised, double-blinded, placebo-controlled, crossover design.

Healthy recreationally active athletes will perform a VO2 max test to determine their aerobic capacity. A blood sample will be taken prior to the test as baseline measurement. Following treatment with iron plus either HydroCurc or a matched placebo for a week, participants will run on a treadmill for one hour at 70% of their maximal capacity. Blood samples will be collected before, immediately after, one hour post- and three hours post-exercise. Gastrointestinal symptoms will be assessed via validated questionnaires during the supplementation period and the experimental visits. All participants will observe a minimum of a two-week washout period. All participants will attend visits fasting for a minimum of four hours.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, W1W6UW
        • University of Westminster London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult (18-40 years) endurance male & female runners.
  • All participants will be accustomed to exercising at least 150 minutes per week, meeting the minimum NHS exercise recommendation.
  • Participants will be fit enough to run for 60 minutes on a treadmill at 70% of their V̇O2max. To that end, participants will undergo a fitness test in the screening visit.

Exclusion Criteria:

  • <18 years or >40 years
  • Those with deficient/excess/abnormal iron levels according to UK guidelines &/or haemochromatosis
  • Any allergies/health issues related to items being ingested.
  • Any illnesses or those on medication
  • Those on iron or curcumin supplements
  • Any pregnant or lactating women
  • Any women who are trying to conceive
  • Any gastrointestinal disorders
  • Any eating disorders
  • Any abnormal blood pressure levels
  • Consumption of >14 units of alcohol/week
  • Devices such as pacemakers
  • Smokers
  • Renal disorders
  • Dieters

These criteria will be self-reported.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Ferrous iron + placebo
  • Dried ferrous sulphate tablet, 200mg providing 65 mg of elemental iron (Remedy Healthcare, UK).
  • Placebo capsule containing maltodextrin and a food grade dye (yellow 5 or E102) (Fast Colours LLP, Huddersfield, UK)
Dietary supplement: Placebo
Participants instructed to intake the placebo capsule along with the ferrous sulphate tablet, separated from food, tea or coffee, at the same time of the day.
Dietary supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron
Participants instructed to intake the ferrous sulphate tablet along with the HydroCurc® or the placebo together, preferably and separated from food, tea or coffee, at the same time of the day.
Active Comparator: Ferrous iron + HydroCurc
  • Dried ferrous sulphate, 200mg tablet providing 65 mg of elemental iron (Remedy Healthcare, UK).
  • HydroCurc (Gencor Pacific Limited, Lantau Island, Hong Kong), 500 mg capsule containing not less than 90% 115 curcuminoids (85% curcumin), formulated in 10% LipiSperse® (Pharmako Biotechnologies Pty Ltd, 116 Sydney, Australia), a delivery system comprising a proprietary mixture of surfactants, polar lipids 117 and solvents.
Dietary supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron
Participants instructed to intake the ferrous sulphate tablet along with the HydroCurc® or the placebo together, preferably and separated from food, tea or coffee, at the same time of the day.
Dietary supplement: HydroCurc®
Participants instructed to intake the HydroCurc® capsule along with the ferrous sulphate tablet, separated from food, tea or coffee, at the same time of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions
Time Frame: Hepcidin measured 1 day post supplementation
Hepcidin, ng/mL
Hepcidin measured 1 day post supplementation
Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron
Time Frame: Hepcidin measured 180 minutes post-exercise
Hepcidin, ng/mL
Hepcidin measured 180 minutes post-exercise
Ferrous iron-associated iron status in athletes
Time Frame: Ferritin measured 1 day post supplementation
Ferritin, ng/mL
Ferritin measured 1 day post supplementation
Change of exercise-associated inflammation in ferrous iron supplemented athletes
Time Frame: Interleukin-6 measured 0- and 60-minutes post-exercise
Interleukin-6, pg/mL
Interleukin-6 measured 0- and 60-minutes post-exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise-associated intestinal damage in ferrous iron supplemented athletes
Time Frame: IFABP measured 0- and 60-minutes post-exercise
Intestinal Fatty Acid Binding Protein (IFABP), pg/mL
IFABP measured 0- and 60-minutes post-exercise
Incidence and frequency of ferrous iron associated-gastrointestinal symptoms
Time Frame: Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days)
Subjective analysis via Oral Iron Supplement Questionnaire
Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days)
Number of participants supplementing with ferrous iron and reporting exercise-associated gastrointestinal symptoms
Time Frame: Gastrointestinal symptoms measured 30 minutes after the commencement of the exercise, 0-, 60- and 180- minutes post-exercise.
Subjective analysis via gastrointestinal symptom questionnaire
Gastrointestinal symptoms measured 30 minutes after the commencement of the exercise, 0-, 60- and 180- minutes post-exercise.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Westminster

Collaborators

Pharmako Biotechnologies Pty Ltd

Investigators

  • Principal Investigator: Mohammed G Zariwala, PhD, University of Westminster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

July 11, 2025

First Submitted That Met QC Criteria

July 11, 2025

First Posted (Actual)

July 22, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETH2223-1363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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