Impact of Genetic Polymorphisms And DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome
What is the Impact of Genetic Polymorphisms and DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome?
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 26, 2025
CompletedFirst Posted
Study publicly available on registry
May 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMay 18, 2025
May 1, 2025
4 months
April 26, 2025
May 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (27)
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.
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.
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.
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.
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)
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)
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)
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)
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).
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).
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).
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).
90 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Baseline
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
30 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
60 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
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.
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.
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.
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.
90 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Baseline
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
30 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
60 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
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).
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).
90 days
Genetic Analysis
Using the Real Time Polymerase Chain Reaction (real-time PCR) system on Step One PlusTM equipment
90 days
Study Arms (1)
Group 1
EXPERIMENTAL30 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- The study population will consist of menopausal women aged between 40 to 60 years old
- Obese (BMI \> 30) with a diagnosis of MS.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nutrindo Ideais Research Center
Rio de Janeiro, 22421-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2025
First Posted
May 18, 2025
Study Start
April 1, 2025
Primary Completion
August 1, 2025
Study Completion
October 30, 2025
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE