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

NCT06457711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-16

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

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

DIETARY_SUPPLEMENT

Intermittent Fasting Group (IFG)

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

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06457711 on ClinicalTrials.gov