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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency (Without Anemia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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FS65_Curc

Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day

Group Type ACTIVE_COMPARATOR

Ferrous Sulphate 65 mg

Intervention Type DIETARY_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

Curcumin

Intervention Type DIETARY_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)

FS65_Plac

Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])

Group Type PLACEBO_COMPARATOR

Ferrous Sulphate 65 mg

Intervention Type DIETARY_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

Placebo (Curcumin)

Intervention Type OTHER

Microcrystalline cellulose

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

FS0_Plac

Placebo (Ferrous Sulphate placebo \[cellulose\]) and Placebo (Curcumin placebo \[cellulose\])

Group Type PLACEBO_COMPARATOR

Placebo (Ferrous Sulphate)

Intervention Type OTHER

Microcrystalline cellulose

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

Placebo (Curcumin)

Intervention Type OTHER

Microcrystalline cellulose

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

FS18_Plac

Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])

Group Type PLACEBO_COMPARATOR

Placebo (Curcumin)

Intervention Type OTHER

Microcrystalline cellulose

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

Ferrous Sulphate 18mg

Intervention Type DIETARY_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

FS18_Curc

Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day

Group Type ACTIVE_COMPARATOR

Curcumin

Intervention Type DIETARY_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)

Ferrous Sulphate 18mg

Intervention Type DIETARY_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

Interventions

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Ferrous Sulphate 65 mg

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

Intervention Type DIETARY_SUPPLEMENT

Curcumin

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)

Intervention Type DIETARY_SUPPLEMENT

Placebo (Ferrous Sulphate)

Microcrystalline cellulose

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

Intervention Type OTHER

Placebo (Curcumin)

Microcrystalline cellulose

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

Intervention Type OTHER

Ferrous Sulphate 18mg

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ferrous Sulfate Turmeric Curcuma longa Ferrous Sulfate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes