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

The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04465851

Acronym

Fe-ROUTINE

Enrollment

155

Registered

2020-07-10

Start date

2018-07-18

Completion date

2020-01-31

Last updated

2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency (Without Anemia)

Keywords

nutraceutical, anti-oxidant, oxidative status, ferrous sulphate, curcumin, inflammatory status, turmeric, gastrointestinal, fatigue, iron, Hydrocurc, supplement

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.

Interventions

DIETARY_SUPPLEMENTFerrous 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

DIETARY_SUPPLEMENTCurcumin

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)

OTHERPlacebo (Ferrous Sulphate)

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

OTHERPlacebo (Curcumin)

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

DIETARY_SUPPLEMENTFerrous 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation	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 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 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	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)

Secondary

Measure	Time frame	Description
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 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)	Subjective analysis including: Visual Analogue Scale for Fatigue (VAS-F). Scores range from 0 to 100 (the higher the score the greater the level of fatigue)
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026