Modulation of hepcidIN With Co-supplementation of Iron and FORMulated Curcumin in Recreational Athletes

NCT07078630 | Completed

• 1 other identifier: ETH2223-1363
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Supplementation and Gastrointestinal Health; Iron Deficiency

Keywords

Iron; Ferrous sulphate; Curcumin; IFABP; Ferritin; Interleukin-6; Hepcidin; Iron deficiency; Anaemia; Inflammation; Oxidative stress; Supplement; Gastrointestinal symptoms; Nutraceutical

Outcome Measures

Primary Outcomes (4)

• Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions

  Hepcidin, ng/mL

  Hepcidin measured 1 day post supplementation

• Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron

  Hepcidin, ng/mL

  Hepcidin measured 180 minutes post-exercise

• Ferrous iron-associated iron status in athletes

  Ferritin, ng/mL

  Ferritin measured 1 day post supplementation

• Change of exercise-associated inflammation in ferrous iron supplemented athletes

  Interleukin-6, pg/mL

  Interleukin-6 measured 0- and 60-minutes post-exercise

Secondary Outcomes (3)

• Exercise-associated intestinal damage in ferrous iron supplemented athletes

  IFABP measured 0- and 60-minutes post-exercise

• Incidence and frequency of ferrous iron associated-gastrointestinal symptoms

  Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days)

• Number of participants supplementing with ferrous iron and reporting exercise-associated gastrointestinal symptoms

  Gastrointestinal symptoms measured 30 minutes after the commencement of the exercise, 0-, 60- and 180- minutes post-exercise.

Study Arms (2)

Ferrous iron + placebo

PLACEBO COMPARATOR

* 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; Dietary Supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron

Ferrous iron + HydroCurc

ACTIVE COMPARATOR

* 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: HydroCurc®; Dietary Supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Ferrous iron + placebo

HydroCurc® DIETARY_SUPPLEMENT

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.

Ferrous iron + HydroCurc

Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron DIETARY_SUPPLEMENT

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.

Ferrous iron + HydroCurc; Ferrous iron + placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Westminster: lead
• Pharmako Biotechnologies Pty Ltd: collaborator

Study Sites (1)

University of Westminster London

London, Greater London, W1W6UW, United Kingdom

Location

Related Publications (7)

• Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.

  PMID: 25700159 BACKGROUND

• Szymanski MC, Gillum TL, Gould LM, Morin DS, Kuennen MR. Short-term dietary curcumin supplementation reduces gastrointestinal barrier damage and physiological strain responses during exertional heat stress. J Appl Physiol (1985). 2018 Feb 1;124(2):330-340. doi: 10.1152/japplphysiol.00515.2017. Epub 2017 Sep 21.

  PMID: 28935827 BACKGROUND

• Peters HP, Bos M, Seebregts L, Akkermans LM, van Berge Henegouwen GP, Bol E, Mosterd WL, de Vries WR. Gastrointestinal symptoms in long-distance runners, cyclists, and triathletes: prevalence, medication, and etiology. Am J Gastroenterol. 1999 Jun;94(6):1570-81. doi: 10.1111/j.1572-0241.1999.01147.x.

  PMID: 10364027 BACKGROUND

• Ishibashi A, Maeda N, Kamei A, Goto K. Iron Supplementation during Three Consecutive Days of Endurance Training Augmented Hepcidin Levels. Nutrients. 2017 Jul 30;9(8):820. doi: 10.3390/nu9080820.

  PMID: 28758951 BACKGROUND

• Laine F, Laviolle B, Bardou-Jacquet E, Fatih N, Jezequel C, Collet N, Ropert M, Morcet J, Hamon C, Reymann JM, Loreal O. Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study. Fundam Clin Pharmacol. 2017 Oct;31(5):567-573. doi: 10.1111/fcp.12288. Epub 2017 May 7.

  PMID: 28370178 BACKGROUND

• Larsuphrom P, Latunde-Dada GO. Association of Serum Hepcidin Levels with Aerobic and Resistance Exercise: A Systematic Review. Nutrients. 2021 Jan 27;13(2):393. doi: 10.3390/nu13020393.

  PMID: 33513924 BACKGROUND

• Keller K, Friedrich O, Treiber J, Quermann A, Friedmann-Bette B. Iron deficiency in athletes: Prevalence and impact on VO2 peak. Nutrition. 2024 Oct;126:112516. doi: 10.1016/j.nut.2024.112516. Epub 2024 Jun 10.

  PMID: 39002373 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia; Inflammation

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed G Zariwala, PhD

  University of Westminster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Physiology

Model Details: Double-blinded, randomised, placebo-controlled, crossover.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: October 5, 2023
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: August 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)