RecruitingNot ApplicableNCT06978504

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?

Sponsor

Nutrindo Ideais Research Center

Enrollment

30 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Weight Loss Metabolic Syndrome Nutrition Genetic Polymorphisms

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.

Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 60 Years

Inclusion Criteria7

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.

Exclusion Criteria9

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.

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Interventions

OTHERDASH diet

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.