Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs
Condition: Iron Deficiency (Without Anemia)
MeSH terms: Iron Deficiencies
Study type: Interventional

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.
    

Intervention name(s): Ferrous Sulphate 65 mg; Curcumin; Placebo (Ferrous Sulphate); Placebo (Curcumin); Ferrous Sulphate 18mg
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other; Dietary Supplement
Intervention description(s): 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; 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); Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach); Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach); 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 intervention name(s): Ferrous Sulfate; Turmeric; Curcuma longa; Ferrous Sulfate
Intervention MeSH terms: Curcumin
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)
Primary purpose: Basic Science
Keywords: nutraceutical; anti-oxidant; oxidative status; ferrous sulphate; curcumin; inflammatory status; turmeric; gastrointestinal; fatigue; iron; Hydrocurc; supplement