Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286748
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-11
Brief Title:
Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Effects of Beetroot Extract Supplementation Associated With an Exercise Protocol on Oxidative Stress Inflammation and Functional Capacity in Patients With Chronic Kidney Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic kidney disease CKD patients often present systemic inflammation and oxidative stress resulting in metabolic disorders and high rates of disease-associated cardiovascular death The literature has indicated that dietary control the use of bioactive compounds and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications In this context beetroot Beta vulgaris rubra deserves attention as it is a source of several bioactive compounds such as nitrate betaine and betalain with beneficial effects for CKD patients including anti-inflammatory antioxidant effects reduction of blood pressure and vasodilatory action The antioxidant and anti-inflammatory properties in addition to their vasodilatory and antihypertensive capacity can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients So this research project will bring contributions to the scientific world providing strategies for application in clinical practice and the care of patients with CKD on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation oxidative stress and improved functional capacity Furthermore when supplemented hours before physical training has been identified as an important factor in improving performance in these activities Therefore this study aims to evaluate the effects of supplementation acute and chronic of beetroot extract associated with an exercise protocol on complications associated with CKD
Detailed Description:
This is an acute and chronic study the acute type being a randomized double-blind crossover clinical trial with a washout period and placebo-controlled trial RCT and the chronic concerns a randomized double-blind placebo-controlled clinical trial type study randomized controlled trial - RCT To calculate the sample size it was assumed that the tumor necrosis factor TNF-alpha concentration would decrease by 10 pgmL after intervention with beetroot juice using the within-patient standard deviation of 23 It was assumed a type I error of P 005 and a test power of 80 and it was estimated that for both the acute and chronic study 25 patients would be needed margin of 10 28 patients with CKD undergoing conservative treatment at the Renal Nutrition Outpatient Clinic Eligible patients of both genders previously evaluated and authorized by the medical and nutritionist staff will be invited to participate in the research in person and verbally during nutritional consultations at the Renal Nutrition Outpatient Clinic The acute intervention study will be divided into 3 stages The first stage will consist of collecting anthropometric data food intake completion of individual quality of life questionnaires SF-36 and physical activity level IPAQ and finally familiarization with the exercise protocol that will be carried out in the following stages Already in second stage initial data will be collected from participants soon after participantes will be invited to perform the 6-minute walk test Then all individuals will be instructed to ingest beetroot juice or placebo and wait for at least 2 hours After 2 hours all volunteers must complete the training protocol lasting 20 minutes At the end of the exercises both groups will be reevaluated Finally in the third and final stage after 14 washout days participants will go through the same process described in the previous stage however participantes will carry out the opposite intervention to that carried out in stage two that is those who participated in the beetroot juice group will become part of the control group and vice versa The chronic intervention study will be similar to the acute intervention stages but individuals will undergo three weekly sessions totaling 24 training sessions 8 weeks without washout period The second stage will begin with the collection of blood samples and vital data of participants as well as the performance For eight weeks volunteers will ingest beetroot juice or control and after 2 hours of rest they must perform the protocol of circuit exercises The end of this stage will be characterized by the collection of blood vital signs data on food intake clinical anthropometric filling out questionnaires SF-36 and IPAC and carrying out Before and after training each practitioners vital signs will be measured by security measure If the resting heart rate is greater than 120 beats per minute bpm systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg the patient will be contraindicated to perform the days training Training should also be stopped if the subject presents chest pain dyspnea lower leg cramps staggering gait intense sweating and paleness recommendations that will also be adopted to perform
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None