Skip to main content
OpenTrials
Completed

NCT Number: NCT04465851

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iron Deficiency (Without Anemia) Fatigue Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Westminster

London, W1W 6UW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulphate 65 mg

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

Other names: Ferrous Sulfate

Curcumin

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)

Other names: Turmeric, Curcuma longa

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 18mg

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

Other names: Ferrous Sulfate

Primary outcomes

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

    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)

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

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

    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)

    Tumour Necrosis Factor alpha (pg/mL)

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

    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)

    Marker: C-Reactive Protein (g/L)

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

    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)

    Marker: thiobarbituric acid reactive substances (μM)

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

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

    Marker: serum iron (μmol/L)

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

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

    Marker: total iron binding capacity (μmol/L)

  7. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

    Time frame: 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)

  8. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

    Time frame: Change in total iron binding capacity (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: total iron binding capacity (μmol/L)

  9. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

    Time frame: Change in ferritin (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: Ferritin (ng/mL)

  10. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

    Time frame: Change in haemoglobin (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: Haemoglobin (g/dL)

  11. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

    Time frame: 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 outcomes

  1. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels

    Time frame: 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)

  2. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects

    Time frame: 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

  3. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue

    Time frame: 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)

  4. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Westminster

Other

Collaborators

  • Gencor Pacific Group

Registry information

Official study title

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

Acronym: Fe-ROUTINE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.