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NCT Number: NCT07078630

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

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

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Key information

Conditions

Iron Supplementation and Gastrointestinal Health Anemia Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Westminster London

London, Greater London, W1W6UW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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 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.

Primary outcomes

  1. 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

  2. Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron

    Time frame: Hepcidin measured 180 minutes post-exercise

    Hepcidin, ng/mL

  3. Ferrous iron-associated iron status in athletes

    Time frame: Ferritin measured 1 day post supplementation

    Ferritin, ng/mL

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Westminster

Other

Collaborators

  • Pharmako Biotechnologies Pty Ltd

Registry information

Official study title

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

Acronym: IN-FORM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Aug 21, 2025

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.

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