Arterial Hypertension, Cardiometabolic Syndrome, Cardiovascular Diseases, Menopause, Obesity
Conditions
Keywords
blood pressure, diet, menopause, women, cardiometabolic risk
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.
Interventions
DIETARY_SUPPLEMENTFree 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_SUPPLEMENTVery 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_SUPPLEMENTIntermittent Fasting Group (IFG)
Participants were offered nutritional guidance and were encouraged to adhere to the principles of the intermittent fasting schedule
Sponsors
University of Roma La Sapienza
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Collaborative consultation encouraged patients to participate. Patient can choose their group of intervention. Dietary regimen were tailored on each patient: the intervention was adapted to patients' needs and to their body composition.
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).
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinic diastolic brachial BP levels. | 6 months | Secondary outcomes included modulation of diastolic blood pressure |
| 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: 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: circumference | 6 months | Secondary outcomes included changes from baseline of waist (WC) and hip circumference (cm), combined in waist-hip ratio (WHR) |
| Body Composition: Bioelectrical impedance analysis (BIA) | 6 months | Secondary outcomes included changes from baseline of Phase Angle ° |
Countries
Italy
Outcome results
None listed