NCT04465851

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: University of Westminster · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Deficiency (Without Anemia)

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	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)
OTHER	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

Timeline

• Start date: 2018-07-18
• Primary completion: 2019-11-11
• Completion: 2020-01-31
• First posted: 2020-07-10
• Last updated: 2020-07-10

Locations

1 site across 1 country: United Kingdom