Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)

Obesity Clinical Trial

Official title: Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity: A Real-World Study (Diet-to-HTN)

Status Completed

Clinical Trial 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 body's overall health status.

Clinical Trial Description

This research was conducted as a single-center, prospective, open-label clinical trial at Sant'Andrea Hospital in Rome, Italy. Participants included menopausal women with a BMI of 25 kg/m² or higher, who were already being treated for uncomplicated hypertension. These women were assessed at the hospital's 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. ;

Related Conditions & MeSH terms

• Arterial Hypertension
• Cardiometabolic Syndrome
• Cardiovascular Diseases
• Hypertension
• Menopause
• Metabolic Syndrome
• Obesity

• NCT number: NCT06457711
• Study type: Interventional
• Source: University of Roma La Sapienza
• Status: Completed
• Phase: N/A
• Start date: June 22, 2022
• Completion date: June 22, 2023