The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
研究概览
简要总结
INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA production, oxygen transport and neuronal processes. However, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular oxidative stress in the body.
Curcumin is an active component found in turmeric, known for its anti-oxidant and anti-inflammatory properties. Co-administration of iron and curcumin may influence iron, inflammatory status and/or neurotrophic markers in the body.
详细描述
Intervention study with five parallel treatment groups in a randomised, double-blind, placebo-controlled design.
Study population: Healthy Participants (Male or Female) will receive daily supplements (active or equivalent placebos) for 6 weeks (42 days)
Biological samples (blood and urine samples) are collected at baseline visit (day 1), mid-point (day 21) and end-point (day 42). In addition, pertinent questionnaires (Visual Analogue Scale-Fatigue [VAS-F] and oral iron supplement questionnaire will be collected at the aforementioned time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants (and supplements) will be coded and randomly allocated (applied randomly by software [gender balanced[) to treatment arms to eliminate order effects and maintain research staff blinding.
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
- •Males & Females (18-40 years of age)
- •Healthy subjects
排除标准
- •<18 years or >40 years
- •Consumption of >21 serving of alcohol/week
- •Any allergies/health issues related to items being ingested
- •Any serious illnesses or those on medication
- •Any pregnant or lactating women
- •Any women who are trying to conceive
- •Any women taking contraceptive medication
- •Any gastrointestinal disorders
- •Any chronic menstrual disorders
- •Any subjects who have undergone the menopause or undergoing the perimenopause transition
- •Any eating disorders
- •Any depression/mental disorders
- •Any abnormal blood pressure levels
- •Those with deficient/excess/abnormal iron levels according to United Kingdom (UK) guidelines &/or haemochromatosis
研究组 & 干预措施
FS65_Curc
Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day
干预措施: Ferrous Sulphate 65 mg (Dietary Supplement)
FS65_Plac
Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
干预措施: Ferrous Sulphate 65 mg (Dietary Supplement)
FS65_Plac
Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
干预措施: Placebo (Curcumin) (Other)
FS0_Plac
Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose])
干预措施: Placebo (Ferrous Sulphate) (Other)
FS0_Plac
Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose])
干预措施: Placebo (Curcumin) (Other)
FS18_Plac
Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
干预措施: Placebo (Curcumin) (Other)
FS18_Plac
Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
干预措施: Ferrous Sulphate 18mg (Dietary Supplement)
FS18_Curc
Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day
干预措施: Ferrous Sulphate 18mg (Dietary Supplement)
FS18_Curc
Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day
干预措施: Curcumin (Dietary Supplement)
FS65_Curc
Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
时间窗: Change in C-Reactive Protein (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: C-Reactive Protein (g/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation
时间窗: Change in thiobarbituric acid reactive substances (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: thiobarbituric acid reactive substances (μM)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
时间窗: Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation
Marker: total iron binding capacity (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
时间窗: Change in red blood cells (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Red blood cells (M/μL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
时间窗: Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
时间窗: Change in Tumour Necrosis Factor alpha (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Tumour Necrosis Factor alpha (pg/mL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
时间窗: Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation
Marker: serum iron (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
时间窗: Change in serum iron (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: serum iron (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
时间窗: Change in total iron binding capacity (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: total iron binding capacity (μmol/L)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
时间窗: Change in ferritin (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Ferritin (ng/mL)
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
时间窗: Change in haemoglobin (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
Marker: Haemoglobin (g/dL)
次要结局
- To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels(Change in BDNF (ELISA) from baseline to endpoint from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint))
- To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects(Change in reported subjective gastrointestinal effects from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint))
- To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue(Change in FSS from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint))
- To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue(Change in VAS-F from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint))
研究者
Mohammed Gulrez Zariwala
Reader in Translational Physiology
University of Westminster