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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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 will be applied by the nutritionist. 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.
Nutrindo Ideais Research Center
Rio de Janeiro, Brazil
RECRUITINGSystolic and Diastolic blood pressure in mmHg
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.
Time frame: Baseline
Systolic and Diastolic blood pressure in mmHg
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.
Time frame: 30 days
Systolic and Diastolic blood pressure in mmHg
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.
Time frame: 60 days
Systolic and Diastolic blood pressure in mmHg
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.
Time frame: 90 days
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Time frame: Baseline
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Time frame: 30 days
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Time frame: 60 days
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Time frame: 90 days
Periodic dietary record forms (24h record)
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).
Time frame: Baseline
Periodic dietary record forms (24h record)
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).
Time frame: 30 days
Periodic dietary record forms (24h record)
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).
Time frame: 60 days
Periodic dietary record forms (24h record)
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).
Time frame: 90 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Time frame: Baseline
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Time frame: 30 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Time frame: 60 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Time frame: 90 days
Waist circumference in centimeters
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.
Time frame: Baseline
Waist circumference in centimeters
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.
Time frame: 30 days
Waist circumference in centimeters
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.
Time frame: 60 days
Waist circumference in centimeters
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.
Time frame: 90 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Time frame: Baseline
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Time frame: 30 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Time frame: 60 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Time frame: 90 days
Blood sample
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).
Time frame: Baseline
Blood sample
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).
Time frame: 90 days
Genetic Analysis
Using the Real Time Polymerase Chain Reaction (real-time PCR) system on Step One PlusTM equipment
Time frame: 90 days
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