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

University of Westminster

Status: Completed

Conditions: Iron Deficiency; Iron Supplementation and Gastrointestinal Health

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07078630

ETH2223-1363

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Ferrous iron + placebo

Placebo Comparator group

Description:

* 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)

Treatment:

Dietary Supplement: Placebo

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

Ferrous iron + HydroCurc

Active Comparator group

Description:

* 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.

Treatment:

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

Dietary Supplement: HydroCurc®