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

Obesity Clinical Trial

Official title:

Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity: A Real-World Study (Diet-to-HTN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06457711
• Other study ID #: NCTBPCMR
• Status: Completed
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: June 2024
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Cardiometabolic Syndrome
• Cardiovascular Diseases
• Hypertension
• Menopause
• Metabolic Syndrome
• Obesity

Intervention

Dietary Supplement:
• Diet
Participants were offered nutritional guidance and were encouraged to adhere to the principles of the dietary recommendations assigned

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinic 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 brachial BP levels (mmHg).	6 months
Secondary	Body composition: BMI	Secondary outcomes included changes from baseline of Body Mass Index (BMI) weight and height will be combined to report BMI in kg/m^2.	6 months
Secondary	Body composition: Fat mass (%)	Secondary outcomes included changes from baseline of Percentage of total body weight loss (TWL %), Body Fat Percentage (BFP %) derived from Bioelectrical impedance analysis (BIA)	6 months
Secondary	Body composition: circumference	Secondary outcomes included changes from baseline of waist (WC) and hip circumference (cm), combined in waist-hip ratio (WHR)	6 months
Secondary	Body Composition: Bioelectrical impedance analysis (BIA)	Secondary outcomes included changes from baseline of Phase Angle °	6 months