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

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

Interventions

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

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.

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.

Sponsors & Collaborators

• Pharmako Biotechnologies Pty Ltd

  collaborator UNKNOWN

• University of Westminster

  lead OTHER

Principal Investigators

• Mohammed G Zariwala, PhD · University of Westminster

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-05

Primary Completion

2024-01-24

Completion

2024-01-24

Countries

• United Kingdom

Study Locations