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

NCT06457711 | Completed

• 1 other identifier: NCTBPCMR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

blood pressure; diet; menopause; women; cardiometabolic risk

Outcome Measures

Primary Outcomes (1)

• Clinic systolic brachial BP levels.

  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).

  6 months

Secondary Outcomes (5)

• Body composition: BMI

  6 months

• Body composition: Fat mass (%)

  6 months

• Body composition: circumference

  6 months

• Body Composition: Bioelectrical impedance analysis (BIA)

  6 months

• Clinic diastolic brachial BP levels.

  6 months

Study Arms (3)

Free diet Group (FDG)

OTHER

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.

Dietary Supplement: Free diet Group (FDG)

Very low Calorie Ketogenic Diet Group (VLCKDG)

EXPERIMENTAL

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.

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

Intermittent Fasting Group (IFG)

ACTIVE COMPARATOR

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.

Dietary Supplement: Intermittent Fasting Group (IFG)

Interventions

Free diet Group (FDG) 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.

Free diet Group (FDG)

Very low Calorie Ketogenic Diet Group (VLCKDG) DIETARY_SUPPLEMENT

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

Very low Calorie Ketogenic Diet Group (VLCKDG)

Intermittent Fasting Group (IFG) DIETARY_SUPPLEMENT

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

Intermittent Fasting Group (IFG)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, RM, 00189, Italy

Location

MeSH Terms

Conditions

Hypertension; Obesity; Metabolic Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Model Details: 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).

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 13, 2024
• Study Start: June 22, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

IT (1)