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

University of Westminster

Status: Completed

Conditions: Iron Deficiency (Without Anemia)

Treatments: Other: Placebo (Ferrous Sulphate); Dietary Supplement: Ferrous Sulphate 65 mg; Other: Placebo (Curcumin); Dietary Supplement: Ferrous Sulphate 18mg; Dietary Supplement: Curcumin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04465851

ETH1718-0907

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 5 patient groups, including a placebo group

FS65_Curc

Active Comparator group

Description:

Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day

Treatment:

Dietary Supplement: Curcumin

Dietary Supplement: Ferrous Sulphate 65 mg

FS65_Plac

Placebo Comparator group

Description:

Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])

Treatment:

Dietary Supplement: Ferrous Sulphate 65 mg

Other: Placebo (Curcumin)

FS0_Plac

Placebo Comparator group

Description:

Placebo (Ferrous Sulphate placebo \[cellulose\]) and Placebo (Curcumin placebo \[cellulose\])

Treatment:

Other: Placebo (Ferrous Sulphate)

Other: Placebo (Curcumin)

FS18_Plac

Placebo Comparator group

Description:

Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])

Treatment:

Dietary Supplement: Ferrous Sulphate 18mg

Other: Placebo (Curcumin)

FS18_Curc

Active Comparator group

Description:

Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day

Treatment:

Dietary Supplement: Curcumin

Dietary Supplement: Ferrous Sulphate 18mg