Clinical trial NCT04465851: Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs
Official title: The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency (Without Anemia)
Keywords: nutraceutical
anti-oxidant
oxidative status
ferrous sulphate
curcumin
inflammatory status
turmeric
gastrointestinal
fatigue
iron
Hydrocurc
supplement
Lead sponsor: University of Westminster
Sponsor class: OTHER
Collaborators: name: Gencor Pacific Group
First posted: 2020-07-10
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
timeFrame: Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
timeFrame: Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
timeFrame: 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 outcomes:
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
timeFrame: 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)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
timeFrame: 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)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of Westminster
Study officials:
References: