Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs (Fe-ROUTINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465851
Recruitment Status : Completed
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Gencor Pacific Group
Information provided by (Responsible Party):
Mohammed Gulrez Zariwala, 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.


Condition or disease Intervention/treatment Phase
Iron Deficiency (Without Anemia) Dietary Supplement: Ferrous Sulphate 65 mg Dietary Supplement: Curcumin Other: Placebo (Ferrous Sulphate) Other: Placebo (Curcumin) Dietary Supplement: Ferrous Sulphate 18mg Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind
Masking: Quadruple (Participant, Care Provider, 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.
Primary Purpose: Basic Science
Official Title: The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : November 11, 2019
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: FS65_Curc
Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day
Dietary Supplement: 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

Other Name: Ferrous Sulfate

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)

Other Names:
  • Turmeric
  • Curcuma longa

Placebo Comparator: FS65_Plac
Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
Dietary Supplement: 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

Other Name: Ferrous Sulfate

Other: Placebo (Curcumin)

Microcrystalline cellulose

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


Placebo Comparator: FS0_Plac
Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose])
Other: Placebo (Ferrous Sulphate)

Microcrystalline cellulose

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


Other: Placebo (Curcumin)

Microcrystalline cellulose

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


Placebo Comparator: FS18_Plac
Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
Other: Placebo (Curcumin)

Microcrystalline cellulose

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


Dietary Supplement: 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

Other Name: Ferrous Sulfate

Active Comparator: FS18_Curc
Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day
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)

Other Names:
  • Turmeric
  • Curcuma longa

Dietary Supplement: 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

Other Name: Ferrous Sulfate




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male or Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465851


Locations
Layout table for location information
United Kingdom
University of Westminster
London, United Kingdom, W1W 6UW
Sponsors and Collaborators
University of Westminster
Gencor Pacific Group
Layout table for additonal information
Responsible Party: Mohammed Gulrez Zariwala, Reader in Translational Physiology, University of Westminster
ClinicalTrials.gov Identifier: NCT04465851    
Other Study ID Numbers: ETH1718-0907
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed Gulrez Zariwala, University of Westminster:
nutraceutical
anti-oxidant
oxidative status
ferrous sulphate
curcumin
inflammatory status
turmeric
gastrointestinal
fatigue
iron
Hydrocurc
supplement
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action