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

University of Roma La Sapienza

Status: Completed

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

Treatments: Dietary Supplement: Intermittent Fasting Group (IFG); Dietary Supplement: Free diet Group (FDG); Dietary Supplement: Very low Calorie Ketogenic Diet Group (VLCKDG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06457711

NCTBPCMR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Free diet Group (FDG)

Other group

Description:

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.

Treatment:

Dietary Supplement: Free diet Group (FDG)

Very low Calorie Ketogenic Diet Group (VLCKDG)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Very low Calorie Ketogenic Diet Group (VLCKDG)

Intermittent Fasting Group (IFG)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Intermittent Fasting Group (IFG)