Iron Deficiency, Iron Supplementation and Gastrointestinal Health
Conditions
Keywords
Iron, Ferrous sulphate, Curcumin, IFABP, Ferritin, Interleukin-6, Hepcidin, Iron deficiency, Anaemia, Inflammation, Oxidative stress, Supplement, Gastrointestinal symptoms, Nutraceutical
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
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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_SUPPLEMENTHydroCurc®
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_SUPPLEMENTFerrous 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
Pharmako Biotechnologies Pty Ltd
University of Westminster
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double-blinded, randomised, placebo-controlled, crossover.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions | Hepcidin measured 1 day post supplementation | Hepcidin, ng/mL |
| Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron | Hepcidin measured 180 minutes post-exercise | Hepcidin, ng/mL |
| Ferrous iron-associated iron status in athletes | Ferritin measured 1 day post supplementation | Ferritin, ng/mL |
| Change of exercise-associated inflammation in ferrous iron supplemented athletes | Interleukin-6 measured 0- and 60-minutes post-exercise | Interleukin-6, pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and frequency of ferrous iron associated-gastrointestinal symptoms | Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days) | Subjective analysis via Oral Iron Supplement Questionnaire |
| 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. | Subjective analysis via gastrointestinal symptom questionnaire |
| Exercise-associated intestinal damage in ferrous iron supplemented athletes | IFABP measured 0- and 60-minutes post-exercise | Intestinal Fatty Acid Binding Protein (IFABP), pg/mL |
Countries
United Kingdom
Outcome results
None listed