Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs
- Conditions
- Iron Deficiency (Without Anemia)
- Interventions
- Other: Placebo (Ferrous Sulphate)Dietary Supplement: Ferrous Sulphate 65 mgDietary Supplement: CurcuminOther: Placebo (Curcumin)Dietary Supplement: Ferrous Sulphate 18mg
- Registration Number
- NCT04465851
- Lead Sponsor
- University of Westminster
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- Males & Females (18-40 years of age)
- Healthy subjects
- <18 years or >40 years
- Dieters
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FS65_Curc Curcumin Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day FS65_Plac Placebo (Curcumin) Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\]) FS0_Plac Placebo (Ferrous Sulphate) Placebo (Ferrous Sulphate placebo \[cellulose\]) and Placebo (Curcumin placebo \[cellulose\]) FS18_Curc Curcumin Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day FS18_Curc Ferrous Sulphate 18mg Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day FS65_Curc Ferrous Sulphate 65 mg Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day FS0_Plac Placebo (Curcumin) Placebo (Ferrous Sulphate placebo \[cellulose\]) and Placebo (Curcumin placebo \[cellulose\]) FS18_Plac Ferrous Sulphate 18mg Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\]) FS65_Plac Ferrous Sulphate 65 mg Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\]) FS18_Plac Placebo (Curcumin) Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])
- Primary Outcome Measures
Name Time Method To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation 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 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 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 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)
- Secondary Outcome Measures
Name Time Method 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) Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)
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) Subjective analysis including: Oral Iron Supplement Questionnaire
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) Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above ≥ 36 indicates fatigue).
Trial Locations
- Locations (1)
University of Westminster
🇬🇧London, United Kingdom