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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06457711
Other study ID # NCTBPCMR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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