Clinical trial NCT06457711: Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)
Official title: Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity: A Real-World Study (Diet-to-HTN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Hypertension
Menopause
Obesity
Cardiometabolic Syndrome
Cardiovascular Diseases
Keywords: blood pressure
diet
menopause
women
cardiometabolic risk
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators enrolled 50 patient to divide in 20 patients in the KD group, 20 in the IF group and 10 in the FD. Seven patients dropped out from their assigned groups as follows: FD (n = 2), IF (n = 3), and KD (n = 2).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinic systolic brachial BP levels.
timeFrame: 6 months
Secondary outcomes:
measure: Body composition: BMI
timeFrame: 6 months
measure: Body composition: Fat mass (%)
timeFrame: 6 months
measure: Body composition: circumference
timeFrame: 6 months
measure: Body Composition: Bioelectrical impedance analysis (BIA)
timeFrame: 6 months
measure: Clinic diastolic brachial BP levels.
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
state: RM
Study officials:
References: