NCT06457711

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: Female
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Free diet Group (FDG)	Participants were offered nutritional guidance and were encouraged to adhere to the principles of the Mediterranean diet and follow the dietary recommendations outlined in Harvard's Healthy Eating Plate.
DIETARY_SUPPLEMENT	Very low Calorie Ketogenic Diet Group (VLCKDG)	Participants were offered nutritional guidance and were encouraged to adhere to the principles of the very low-calorie ketogenic diet (VLCKD) protocol
DIETARY_SUPPLEMENT	Intermittent Fasting Group (IFG)	Participants were offered nutritional guidance and were encouraged to adhere to the principles of the intermittent fasting schedule

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2024-06-13
• Last updated: 2024-07-16

Locations

1 site across 1 country: Italy