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

Not Applicable

Completed

• Conditions: Cardiometabolic Syndrome; Menopause; Cardiovascular Diseases; Arterial Hypertension; Obesity

• Registration Number: NCT06457711
• Lead Sponsor: University of Roma La Sapienza

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 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.

Study Timeline

• Study Start: 2022-06-22
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Study First Submitted: 2024-06-01
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-13
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• female individuals,
• aged between 50 and 65 years,
• BMI ≥25 kg/m2;
• diagnosis of essential uncomplicated arterial hypertension for at least 6 months;
• perimenopause or menopause confirmed,
• provision of informed consent.

Exclusion Criteria

• previous history of major CVDs;
• severe heart or renal failure;
• poor adherence to prescribed pharmacological and non-pharmacological treatments;
• treated uncontrolled hypertension or diabetes;
• secondary forms of hypertension;
• uncontrolled thyroid diseases;
• previous bariatric surgery or endoscopic bariatric procedures;
• regular engagement in competitive sports activities;
• history of alcoholism and/or drug addiction;
• psychiatric and/or neurological conditions affecting the understanding and giving of informed consent;
• cancer or any other progressive severe disease;
• use of pharmacological treatments known to may interfere with the main purposes of the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinic systolic brachial BP levels.	6 months	The primary aim was to evaluate the effects of Very low calorie Ketogenic Diet or intermittent fasting compared to Free Diet on clinic systolic brachial BP levels (mmHg).

Secondary Outcome Measures

Name	Time	Method
Body composition: circumference	6 months	Secondary outcomes included changes from baseline of waist (WC) and hip circumference (cm), combined in waist-hip ratio (WHR)
Body composition: Fat mass (%)	6 months	Secondary outcomes included changes from baseline of Percentage of total body weight loss (TWL %), Body Fat Percentage (BFP %) derived from Bioelectrical impedance analysis (BIA)
Body composition: BMI	6 months	Secondary outcomes included changes from baseline of Body Mass Index (BMI) weight and height will be combined to report BMI in kg/m\^2.
Body Composition: Bioelectrical impedance analysis (BIA)	6 months	Secondary outcomes included changes from baseline of Phase Angle °
Clinic diastolic brachial BP levels.	6 months	Secondary outcomes included modulation of diastolic blood pressure

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Rome, RM, Italy