Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs
Słowa kluczowe
Abstrakcyjny
Opis
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.
Daktyle
| Ostatnia weryfikacja: | 06/30/2020 |
| Pierwsze przesłane: | 06/22/2020 |
| Szacowana liczba przesłanych rejestracji: | 07/05/2020 |
| Wysłany pierwszy: | 07/09/2020 |
| Ostatnia aktualizacja przesłana: | 07/05/2020 |
| Ostatnia opublikowana aktualizacja: | 07/09/2020 |
| Rzeczywista data rozpoczęcia badania: | 07/17/2018 |
| Szacowana data zakończenia podstawowej działalności: | 11/10/2019 |
| Szacowana data zakończenia badania: | 01/30/2020 |
Stan lub choroba
Interwencja / leczenie
Dietary Supplement: Ferrous Sulphate 65 mg
Dietary Supplement: Curcumin
Other: FS0_Plac
Other: Placebo (Curcumin)
Dietary Supplement: Ferrous Sulphate 18mg
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Active Comparator: FS65_Curc Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day | |
| Placebo Comparator: FS65_Plac Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose]) | |
| Placebo Comparator: FS0_Plac Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose]) | Other: FS0_Plac Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) |
| Placebo Comparator: FS18_Plac Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose]) | |
| Active Comparator: FS18_Curc Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | 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 |
Wynik
Podstawowe miary wyników
1. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation [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)]
2. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation [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)]
3. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation [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)]
4. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation [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)]
5. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption [Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation]
6. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption [Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation]
7. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status [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)]
8. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status [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)]
9. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status [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)]
10. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status [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)]
11. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status [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)]
Miary wyników wtórnych
1. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels [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)]
2. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects [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)]
3. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue [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)]
4. To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue [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)]
