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

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

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

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

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

Iron Deficiency (Without Anemia)

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

Ferrous Sulphate 65 mg

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)

Curcumin

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

Placebo (Ferrous Sulphate)

Placebo (Curcumin)

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

Ferrous Sulphate 18mg

University of Westminster

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

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

Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)

Marker: thiobarbituric acid reactive substances (μM)

Marker: total iron binding capacity (μmol/L)

Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)

Subjective analysis including: Oral Iron Supplement Questionnaire

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)

Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above ≥ 36 indicates fatigue).

Mohammed Gulrez Zariwala

Reader in Translational Physiology

Gencor Pacific Group

Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind

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.

The subjects assumed daily 250 ml of fortified milk for 12 weeks.

The subjects assumed daily 250 ml of placebo milk for 12 weeks.

Sleep Disorders

Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose <0.01%), enriched in whey protein (5%) and calcium (0.24%), supplemented with unsaturated fatty acids omega-3 (DHA + EPA), vitamins (D, B12, B6, B9, E, C), prebiotics (FOS) and phyto curcuminoids (sunflower lecithin). Milk had to be associated with a packet of lyophilized and concentrated probiotics (Bifidobacteria infant-type and / or Lactobacilli), at the time of consumption. Milk and probiotics had been produced or supplied by Granarolo s.p.a.

Fortified milk

Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose <0.01%) with standard proteins of milk (3.1%) and color additive "quantum satis". Milk had to be associated with a packet of maltodextrin "Food Grade", at the time of consumption. Milk and maltodextrin had been produced or supplied by Granarolo s.p.a.

Placebo milk

University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine

Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia

Promotion of Consumer's Health: Nutritional Enhancement/Valorization of Agrofood Italian Traditional Products (PROS.IT)

Stress was evaluated by PSS questionnaire and 24-h urinary cortisol levels

Dosage in plasma of the following cytokines: IL-1β, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, IFN-γ, sCD40L, TNF-α, IL-17 A/F by Elisa immunoassay.

Plasmatic N-glycans by capillary electrophoresis (DSA-FACE).

Stress was evaluated by BDI-II questionnaire

Epigenetic analysis of ELOVL2, FHL2, PENK genes by "Sequenom"

Analysis of gut-microbiota composition by 454 Pyrosequencing of the V4 region of the 16S rRNA gene.

Claudio Franceschi

Professor emeritus

University of Bologna

200 mg, curcuminoids, 7d of supplementation in capsular form

Vascular Stiffness

Placebo

The Effects of Repeated Bouts of Downhill Running and Curcumin Supplementation on Arterial Stiffness During Recovery

This will be measured using arterial tonometry

Interleukin-6, highsensitivity C-reactive protein, Creatine Kinase

Dr. Jamie Burr

Assistant Professor

University of Prince Edward Island

OmniActive Health Technologies

Placebo
Placebo: daily placebo for 6 weeks

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The primary outcome to be measured will be the change in NF-kB DNA binding (measured in peripheral blood mononuclear cells as ng/well) after six weeks of treatment with daily placebo or Meriva. NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

PBMC NF-kB DNA Binding Measured in ng/Well

The secondary outcome to be measured will be the change in plasma TNF-alpha after six weeks of treatment with daily placebo or Meriva. Plasma TNF-alpha is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

Plasma TNF-alpha

The secondary outcome to be measured will be the change in plasma sTNFR2 (in pg/ml) after six weeks of treatment with daily placebo or Meriva. Plasma sTNFR2 is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

Plasma sTNFR2 Measured in pg/ml

The secondary outcome to be measured will be the change in plasma IL-1ra (in pg/ml) after six weeks of treatment with daily placebo or Meriva. Plasma IL-1ra is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

Plasma IL-1ra Measured in pg/ml

The primary outcome to be measured will be the change in plasma IL-6 after six weeks of treatment with daily placebo or Meriva.

Plasma IL-6 Measured in pg/ml

The primary outcome to be measured will be the change in plasma CRP after six weeks of treatment with daily placebo or Meriva.

Plasma C-reactive Protein (CRP) Measured in mg/L

The secondary outcome to be measured will be the change in fatigue (as measured by the Multidimensional Fatigue Inventory [MFI] total score) after six weeks of treatment with daily placebo or Meriva. The MFI is a 20-item scale designed to evaluate fatigue. Respondents use a scale ranging from 1 to 5 for each item to indicate how statements regarding fatigue represent their experiences. The range of scores is from a minimum of 20 and a maximum of 100. Higher total scores correspond with more acute levels of fatigue.

curcumin/fatigue

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

Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia

The Effects of Repeated Bouts of Downhill Running and Curcumin Supplementation on Arterial Stiffness During Recovery

Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy

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