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NCT Number: NCT06978504

Impact of Genetic Polymorphisms And DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome

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.

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Key information

Conditions

Nutrition Body Weight Body Weight Changes Genetic Polymorphisms Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutrindo Ideais Research Center

Rio de Janeiro, 22421-000, Brazil

Location status: Recruiting

Location contact

GUILHERME RENKE, MD MSc

CONTACT

[email protected]

+5521976959339

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

DASH diet

Other

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.

Primary outcomes

  1. Systolic and Diastolic blood pressure in mmHg

    Time frame: Baseline

    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.

  2. Systolic and Diastolic blood pressure in mmHg

    Time frame: 30 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.

  3. Systolic and Diastolic blood pressure in mmHg

    Time frame: 60 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.

  4. Systolic and Diastolic blood pressure in mmHg

    Time frame: 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.

  5. Body composition and body fat percentage

    Time frame: Baseline

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)

  6. Body composition and body fat percentage

    Time frame: 30 days

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)

  7. Body composition and body fat percentage

    Time frame: 60 days

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)

  8. Body composition and body fat percentage

    Time frame: 90 days

    Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)

  9. Periodic dietary record forms (24h record)

    Time frame: Baseline

    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).

  10. Periodic dietary record forms (24h record)

    Time frame: 30 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).

  11. Periodic dietary record forms (24h record)

    Time frame: 60 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).

  12. Periodic dietary record forms (24h record)

    Time frame: 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).

  13. Body Mass Index (BMI)

    Time frame: Baseline

    Weight in kg and height in meters will be used to calculate BMI

  14. Body Mass Index (BMI)

    Time frame: 30 days

    Weight in kg and height in meters will be used to calculate BMI

  15. Body Mass Index (BMI)

    Time frame: 60 days

    Weight in kg and height in meters will be used to calculate BMI

  16. Body Mass Index (BMI)

    Time frame: 90 days

    Weight in kg and height in meters will be used to calculate BMI

  17. Waist circumference in centimeters

    Time frame: Baseline

    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.

  18. Waist circumference in centimeters

    Time frame: 30 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.

  19. Waist circumference in centimeters

    Time frame: 60 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.

  20. Waist circumference in centimeters

    Time frame: 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.

  21. Height in centimeters

    Time frame: Baseline

    Height will be measured to the nearest 0.1 cm using a certified stadiometer

  22. Height in centimeters

    Time frame: 30 days

    Height will be measured to the nearest 0.1 cm using a certified stadiometer

  23. Height in centimeters

    Time frame: 60 days

    Height will be measured to the nearest 0.1 cm using a certified stadiometer

  24. Height in centimeters

    Time frame: 90 days

    Height will be measured to the nearest 0.1 cm using a certified stadiometer

  25. Blood sample

    Time frame: Baseline

    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).

  26. Blood sample

    Time frame: 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).

  27. Genetic Analysis

    Time frame: 90 days

    Using the Real Time Polymerase Chain Reaction (real-time PCR) system on Step One PlusTM equipment

Study contacts

Contact information is provided by the study sponsor or research team.

Guilherme Renke, MD MSc

CONTACT

[email protected]

+552197695-9339

Sponsors and collaborators

Lead sponsor

Nutrindo Ideais Research Center

Network

Collaborators

  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

What is the Impact of Genetic Polymorphisms and DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome?

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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