Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs

Not Applicable

Completed

• Conditions: Iron Deficiency (Without Anemia)

• 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.

Study Timeline

• Study Start: 2018-07-18
• Primary Completion: 2019-11-11
• Study Completion: 2020-01-31
• Study First Submitted: 2020-06-23
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Males & Females (18-40 years of age)
• Healthy subjects

Exclusion Criteria

• <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

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