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

Iron Deficiency (Without Anemia) Clinical Trial

— Fe-ROUTINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465851
• Other study ID #: ETH1718-0907
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2020
• Source: University of Westminster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 31, 2020
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency (Without Anemia)

Intervention

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
• 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:
• Placebo (Ferrous Sulphate)
Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
• 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

Locations

Country	Name	City	State
United Kingdom	University of Westminster	London

Sponsors (2)

Lead Sponsor	Collaborator
University of Westminster	Gencor Pacific Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation	Tumour Necrosis Factor alpha (pg/mL)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation	Marker: C-Reactive Protein (g/L)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation	Marker: thiobarbituric acid reactive substances (µM)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption	Marker: serum iron (µmol/L)	Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption	Marker: total iron binding capacity (µmol/L)	Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status	Marker: serum iron (µmol/L)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status	Marker: total iron binding capacity (µmol/L)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status	Marker: Ferritin (ng/mL)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status	Marker: Haemoglobin (g/dL)	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)
Primary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status	Marker: Red blood cells (M/µL)	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)
Secondary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels	Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)	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)
Secondary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects	Subjective analysis including: Oral Iron Supplement Questionnaire	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)
Secondary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue	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)	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)
Secondary	To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue	Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above = 36 indicates fatigue).	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)