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| Name | Class |
|---|---|
| Pharmako Biotechnologies Pty Ltd | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous iron + placebo | Placebo Comparator |
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| Ferrous iron + HydroCurc | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise-associated intestinal damage in ferrous iron supplemented athletes | Intestinal Fatty Acid Binding Protein (IFABP), pg/mL | IFABP measured 0- and 60-minutes post-exercise |
| Incidence and frequency of ferrous iron associated-gastrointestinal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
These criteria will be self-reported.
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed G Zariwala, PhD | University of Westminster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Westminster London | London | Greater London | W1W6UW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25700159 | Background | 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. | |
| 28935827 | 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. |
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Double-blinded, randomised, placebo-controlled, crossover.
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| 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. |
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| 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. |
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Subjective analysis via Oral Iron Supplement Questionnaire |
| Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days) |
| Number of participants supplementing with ferrous iron and reporting exercise-associated gastrointestinal symptoms | Subjective analysis via gastrointestinal symptom questionnaire | Gastrointestinal symptoms measured 30 minutes after the commencement of the exercise, 0-, 60- and 180- minutes post-exercise. |
| 10364027 | 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. |
| 28758951 | 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. |
| 28370178 | 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. |
| 33513924 | 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. |
| 39002373 | 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. |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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