What is the Impact of Genetic Polymorphisms and DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Systolic and Diastolic blood pressure in mmHg
研究概览
简要总结
Metabolic syndrome is a multifactorial inflammatory condition that is very prevalent in overweight women with type 2 diabetes. However, there seems to be great benefit in changing lifestyle and dietary patterns in the treatment of this condition. Currently, few studies have shown the effect of a Dietary Approach to Stop Hypertension (DASH) diet in postmenopausal women with metabolic syndrome and the influence of genetic polymorphisms of the fat mass and obesity-associated protein (FTO) and beta-2 adrenergic receptor (ADRB2) genes on inflammatory markers and improvement of laboratory indicators in these patients. This study aims to analyze the interaction of polymorphisms in the ADRB2 and FTO genes and the DASH diet on anthropometric indicators and laboratory tests in patients with metabolic syndrome in the city of Rio de Janeiro. For this purpose, laboratory tests and anthropometric data will be collected in a prospective study with women aged between 40 and 60 years.
详细描述
Prospective, single-arm, unblinded clinical trial lasting 90 days. The study population will consist of menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have an in-person consultation with a nutritionist at t0 to assess their previous habitual food intake and will receive a DASH diet. To minimize losses during the study, in-person consultations with a nutritionist will be held at t0, t30, t60, t90, and online consultations (teleconsultation) at t15, t45 and t75 to answer a questionnaire to assess nutritional adherence that the nutritionist will apply. Saliva samples will be collected for genetic panel analysis only at t90. Serum samples for analysis of lipid profile, blood glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), follicle stimulating hormone (FSH), C-reactive protein (CRP) and tumor necrosis factor (TNF) and profile of medications used will be collected at t0 and t90.
Only one nutritionist will make the dietary prescription to maintain the standardization of the research. The diets will be previously calculated, varying from 100 to 100 kcal (1400 to 2600 kcal) based on the patients' total energy value (TEV). The isocaloric, balanced, and individualized diet will be calculated according to the resting metabolic rate (RMR) obtained by the prediction equation and multiplied by the corresponding activity factor to obtain the TEV. The DASH eating plan will consist of fruits, vegetables, legumes, whole grains, and low-fat dairy products. White meat will be prioritized over red meat, seeds and oilseeds will be included, and sweets and foods rich in sodium will be limited.
Dietary assessment will be performed using periodic dietary record forms (24-hour records) for three non-consecutive days, two typical days, and one atypical day, to analyze the participants' eating habits before the dietary intervention. The participants will complete periodic records at seven points before the intervention begins at t15, t30, t45, t60, t75, and at the end of the 90-day study. The nutritionist will review all forms to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation) and notes that could raise questions later (few items recorded, unknown foods, errors in household measurements, and absence of any meal).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The study population will consist of menopausal women aged between 40 to 60 years old
- •Obese (BMI > 30) with a diagnosis of MS.
- •The inclusion criteria are the presence of at least 3 of the 5 criteria* for MS, which include:
- •Abnormal waist circumference values (≥89 cm in women)
- •SBP ≥120 mm Hg and DBP ≥80 mm Hg) or diagnosis of hypertension
- •Fasting blood glucose equal to or greater than 100 mg/dL or diagnosis of DM2
- •HDL-c less than 50 mg/dL in women
- •Triglycerides ≥150 mg/dL.
排除标准
- •Patients with a BMI <25 kg/m2
- •The following chronic diseases will not be eligible:
- •Active cancer
- •Active tuberculosis
- •Psychiatric illnesses
- •Multiple sclerosis
- •Severe nephropathy
- •Advanced stages of Paget's disease.
- •These chronic conditions could interfere with the results of this study, especially adherence to diet and weight loss. Patients who do not complete all stages of the study, who are not adhering to the intervention or who present any complication that interferes with the results of the study will be excluded from the study.
研究组 & 干预措施
Group 1
30 menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have in-person and online consultations with a nutritionist every 15 days for 3 months to assess their previous habitual food intake and their nutritional adherence to DASH Diet.
干预措施: DASH diet (Other)
结局指标
主要结局
Systolic and Diastolic blood pressure in mmHg
时间窗: 90 days
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Body composition and body fat percentage
时间窗: 90 days
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Periodic dietary record forms (24h record)
时间窗: 90 days
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Body Mass Index (BMI)
时间窗: 90 days
Weight in kg and height in meters will be used to calculate BMI
Waist circumference in centimeters
时间窗: 90 days
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Genetic Analysis
时间窗: 90 days
Using the Real Time Polymerase Chain Reaction (real-time PCR) system on Step One PlusTM equipment
Height in centimeters
时间窗: 90 days
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Blood sample
时间窗: 90 days
blood: collection after 12 hours of fasting, with evaluation of lipid profile (total cholesterol, triglycerides, low-density LDL cholesterol, high-density HDL cholesterol, very low-density VLDL cholesterol), blood glucose, glycated hemoglobin (HbA1c), inflammatory markers C-reactive protein (CRP-T) and tumor necrosis factor (TNF).
次要结局
未报告次要终点
