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

NCT ID: NCT06457711

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2023-06-22

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Free diet Group (FDG)

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Very low Calorie Ketogenic Diet Group (VLCKDG)

Intervention Type: DIETARY_SUPPLEMENT

Participants were offered nutritional guidance and were encouraged to adhere to the principles of the very low-calorie ketogenic diet (VLCKD) protocol

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.

Group Type: ACTIVE_COMPARATOR

Intermittent Fasting Group (IFG)

Intervention Type: DIETARY_SUPPLEMENT

Participants were offered nutritional guidance and were encouraged to adhere to the principles of the intermittent fasting schedule

Interventions

Free 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.

Intervention Type: DIETARY_SUPPLEMENT

Very 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

Intervention Type: DIETARY_SUPPLEMENT

Intermittent Fasting Group (IFG)

Participants were offered nutritional guidance and were encouraged to adhere to the principles of the intermittent fasting schedule

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giuliano Tocci

Associate Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sapienza University of Rome

Rome, RM, Italy

Countries

Italy

Other Identifiers

NCTBPCMR

Identifier Type: -

Identifier Source: org_study_id