Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)
- Conditions
- Cardiometabolic SyndromeMenopauseCardiovascular DiseasesArterial HypertensionObesity
- Interventions
- Dietary Supplement: Very low Calorie Ketogenic Diet Group (VLCKDG)Dietary Supplement: Free diet Group (FDG)Dietary Supplement: Intermittent Fasting Group (IFG)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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
- Arm && Interventions
Group Intervention Description Very low Calorie Ketogenic Diet Group (VLCKDG) Very low Calorie Ketogenic Diet Group (VLCKDG) the very low-calorie ketogenic diet (VLCKD) protocol involved limited carbohydrate consumption to less than 30 grams per day. The protocol suggested a protein intake ranging from 1 to 1.5 grams per kilogram of ideal body weight, with fats limited to 15-30 grams per day and total daily calories estimated between 600 and 800 kcal. During the initial three-week phase of the diet, participants replaced two meals per day with meal replacements-specifically, breakfast and one other main meal were substituted with a protein shake. Accompanying the shake for the main meal were low-glycemic-index vegetables in prescribed quantities. Free diet Group (FDG) Free diet Group (FDG) participants were offered nutritional guidance without strict limitations, but were encouraged to adhere to the principles of the Mediterranean diet and follow the dietary recommendations outlined in Harvard's Healthy Eating Plate. Intermittent Fasting Group (IFG) Intermittent Fasting Group (IFG) Our participant followed an intermittent fasting schedule, specifically the 16/8 method, which involves eating only during an eight-hour window each day and fasting for the subsequent sixteen hours. This eating period began at 12:00 noon and ended at 8:00 PM. During this window, the patient consumed three meals, each with a caloric value reduced by 25% from their total daily energy expenditure. The meals were based on the Mediterranean diet, focusing on the balance and quality of macronutrients.
- 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
Sapienza University of Rome🇮🇹Rome, RM, Italy