Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity: A Real-World Study (Diet-to-HTN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinic systolic brachial BP levels.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Free diet Group (FDG) (Dietary Supplement)
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.
干预措施: Very low Calorie Ketogenic Diet Group (VLCKDG) (Dietary Supplement)
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.
干预措施: Intermittent Fasting Group (IFG) (Dietary Supplement)
结局指标
主要结局
Clinic systolic brachial BP levels.
时间窗: 6 months
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).
次要结局
- Body composition: circumference(6 months)
- Body composition: Fat mass (%)(6 months)
- Body composition: BMI(6 months)
- Body Composition: Bioelectrical impedance analysis (BIA)(6 months)
- Clinic diastolic brachial BP levels.(6 months)
研究者
Giuliano Tocci
Associate Professor of Cardiology
University of Roma La Sapienza