Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457711
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-01
Brief Title:
Blood Pressure and Cardiometabolic Risk Diet-to-HTN
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity A Real-World Study Diet-to-HTN
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Obesity is a significant health issue that increases the risk of serious cardiovascular problems In recent years two dietary methods the Ketogenic Diet KD and Intermittent Fasting IF have become popular for their potential to treat obesity and its related issue hypertension While both diets are known for their effectiveness in weight loss their specific impacts on blood pressure BP and overall heart health risks are less understood especially in menopausal women
The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular unrestricted diet referred to as Free Diet or FD in terms of their effects on clinic blood pressure levels in menopausal women
Additionally the study looked at changes in Body Mass Index BMI the percentage of total body weight loss body fat percentage waist and hip measurements the ratio of waist-to-hip size and the Phase Angle PhA which is a measure of the bodys overall health status
The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular unrestricted diet referred to as Free Diet or FD in terms of their effects on clinic blood pressure levels in menopausal women
Additionally the study looked at changes in Body Mass Index BMI the percentage of total body weight loss body fat percentage waist and hip measurements the ratio of waist-to-hip size and the Phase Angle PhA which is a measure of the bodys overall health status
Detailed Description:
This research was conducted as a single-center prospective open-label clinical trial at SantAndrea Hospital in Rome Italy Participants included menopausal women with a BMI of 25 kgm² or higher who were already being treated for uncomplicated hypertension These women were assessed at the hospitals Hypertension Unit and then placed into one of three diet groups Ketogenic Diet Intermittent Fasting or Free Diet Each participant received personalized dietary advice underwent regular blood pressure checks aligned with European health guidelines and completed standard health tests including electrocardiograms and blood tests for glucose lipids and liver and kidney functions Measurements of all key health indicators were taken at the start of the study then again after two months and six months
This study is designed to offer clearer insights into how specific dietary choices can affect cardiovascular health and help manage hypertension in obese individuals
This study is designed to offer clearer insights into how specific dietary choices can affect cardiovascular health and help manage hypertension in obese individuals
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