Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
Raktažodžiai
Santrauka
apibūdinimas
This is a longitudinal study with a randomized crossover design, double-blind, placebo-controlled, and with washout period. Thirty non-dialysis patients of both genders, aged between 18 and 60 years and with CKD stage3-4 (glomerular filtration rate < 59 mL/min/1.73 m2) will be included in the study. Pregnant patients, smokers and those under use of antibiotics in the last 3 months, or in use antithrombotic, pre-, pro- or synbiotic supplements, antioxidant supplements or habitual cranberry intake will be excluded. In addition, those with autoimmune and infectious diseases, cancer, liver diseases and HIV will also not be included in the study. The patients that fulfill the eligible criteria and sign the ethical informed consent will be randomized to either Group A (Cranberry) or Group B (Placebo). During 12 weeks, patients allocated in group A will receive capsules containing cranberry extract (Vaccinium macrocarpon to 25% anthocyanosides 160mg, equivalent to 40mg anthocyanosides), once daily (lunch), totaling 500mg / day and those allocated in the group B will receive a placebo (500mg of corn starch). After the supplementation period, a 12-week washout will be performed for subsequent crossover of the supplement. The randomization will be computed in the ratio of 1: 1, with block size of 15 (Cranberry group and Control), to receive cranberry or placebo. This project was approved by the Ethics Committee of the Faculty of Medicine-UFF, n. 2.653.752.
Datos
| Paskutinį kartą patikrinta: | 04/30/2020 |
| Pirmasis pateikimas: | 09/27/2018 |
| Numatytas registravimas pateiktas: | 05/02/2020 |
| Pirmas paskelbtas: | 05/06/2020 |
| Paskutinis atnaujinimas pateiktas: | 05/02/2020 |
| Paskutinis atnaujinimas paskelbtas: | 05/06/2020 |
| Faktinė studijų pradžios data: | 07/31/2018 |
| Numatoma pirminio užbaigimo data: | 11/30/2021 |
| Numatoma studijų užbaigimo data: | 11/30/2021 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: Cranberry
Dietary Supplement: Placebo
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Active Comparator: Cranberry Administration of 2 capsules with 500mg (Miralys Ltda) of cranberry extract per day, for 8 weeks | Dietary Supplement: Cranberry The patients will receive 2 capsules per day containing 500mg of cranberry extract for 8 weeks |
| Placebo Comparator: Placebo Administration of 2 capsules with 500mg of maize starch per day, for 8 weeks | Dietary Supplement: Placebo The patients will receive 2 capsules per day containing 500mg of maize starch for 8 weeks |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Clinical diagnosis of Chronic Kidney Disease in conservative treatment - Aged 18 years or older - Must be able to swallow tablets Exclusion Criteria: - Patients pregnant - Smokers - Using antibiotics in the last 3 months - Using antioxidant supplements in the last 3 months - Usual intake of cranberry fruit or extract - Clinical diagnosis of infectious diseases - Clinical diagnosis of Cancer - Clinical diagnosis of AIDS |
Rezultatas
Pirminės rezultatų priemonės
1. Antioxidants and anti-inflammatory biomarkers [3 months]
2. Inflammatory biomarkers [3 months]
3. Biochemical Routine [12 weeks]
4. Uremic toxins [6 months]
