Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387784
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2024-04-16
Brief Title:
Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Acute Effect of Beetroot Juice Supplementation in Pregnant Women With Pre-eclampsia a Single-Blind Randomized Placebo-Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
BEET_PE
Brief Summary:
Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy characterized by high blood pressure and damage to organs such as the kidneys and liver Currently treatment options are limited which has prompted researchers to explore alternative approaches One such promising alternative is dietary nitrate found in vegetables like beetroot as nitrate can be converted into nitric oxide in the body which helps lower blood pressure This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure several blood and salivary markers in pregnant women with pre-eclampsia Furthermore the study will assess fetal blood flow using Doppler ultrasound The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response Through this investigation the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia
Detailed Description:
The study will include women diagnosed with either early-onset pre-eclampsia or late-onset pre-eclampsia following the guidelines of the American College of Obstetricians and Gynecologists Participants will be required to sign informed consent forms following a thorough explanation of the study A total of four groups will be established with twenty-four pregnant women randomly assigned to each group using a free online program In each group early-onset and late-onset pre-eclampsia forty-eight pregnant women will receive nitrate-enriched beetroot juice Beet It James White UK while another forty-eight will receive an equivalent amount of placebo juice The trial will commence in the morning between 730 and 830 am after a standardized low-nitrate breakfast provided by the hospital Participants will be instructed to avoid nitrate-rich foods the previous evening and will receive guidance from the project team and the hospitals nutrition service The hospitals nutritional team will oversee the dietary procedures Ambulatory blood pressure monitoring will be conducted for six hours following the ingestion of juice or placebo Saliva samples will be collected to assess nitrate reductase activity and blood samples will be drawn to measure nitrate nitrite and nitrosothiol nitric oxide metabolites as well as to perform biochemical analyses of oxidative stress Doppler ultrasound and Doppler velocimetry evaluation will be conducted at the peak action time of nitrate which is estimated to occur two hours post-ingestion based on previous research
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