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

University of Westminster155 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

155

Conditions

Iron Deficiency (Without Anemia)

Ferrous Sulphate 65 mgDIETARY_SUPPLEMENT

Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content) Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules

CurcuminDIETARY_SUPPLEMENT

HydroCurc™ 500 mg formulated curcumin At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

Placebo (Ferrous Sulphate)OTHER

Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

Placebo (Curcumin)OTHER

Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

Ferrous Sulphate 18mgDIETARY_SUPPLEMENT

Oral ferrous salt supplement Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content) Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Westminster

London, United Kingdom

Outcomes

Primary Outcomes

To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation

Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)

Time frame: 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)

To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation

Tumour Necrosis Factor alpha (pg/mL)

Time frame: 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)

To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation

Marker: C-Reactive Protein (g/L)

Time frame: 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)

To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation

Marker: thiobarbituric acid reactive substances (μM)

Time frame: 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)

To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption

Marker: serum iron (μmol/L)

Time frame: Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation

To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption

Marker: total iron binding capacity (μmol/L)

Time frame: Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation