Co-supplementation of Ferrous Iron With Formulated Curcumin Reduces Hepcidin Response in Trained Individuals: a Cross-over, Double-blinded, Placebo-controlled Human Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •<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
- •Renal disorders
- •These criteria will be self-reported.
研究组 & 干预措施
Ferrous iron + placebo
- 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)
干预措施: Placebo (Dietary Supplement)
Ferrous iron + placebo
- 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)
干预措施: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron (Dietary Supplement)
Ferrous iron + HydroCurc
- 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.
干预措施: HydroCurc® (Dietary Supplement)
Ferrous iron + HydroCurc
- 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.
干预措施: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron (Dietary Supplement)
结局指标
主要结局
Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions
时间窗: Hepcidin measured 1 day post supplementation
Hepcidin, ng/mL
Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron
时间窗: Hepcidin measured 180 minutes post-exercise
Hepcidin, ng/mL
Change of exercise-associated inflammation in ferrous iron supplemented athletes
时间窗: Interleukin-6 measured 0- and 60-minutes post-exercise
Interleukin-6, pg/mL
Ferrous iron-associated iron status in athletes
时间窗: Ferritin measured 1 day post supplementation
Ferritin, ng/mL
次要结局
- Exercise-associated intestinal damage in ferrous iron supplemented athletes(IFABP measured 0- and 60-minutes post-exercise)
- Incidence and frequency of ferrous iron associated-gastrointestinal symptoms(Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days))
- 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.)
研究者
Mohammed Gulrez Zariwala
Professor of Translational Physiology
University of Westminster