CompletedNot Applicable

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

Brazil30 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range

40 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Systolic and Diastolic blood pressure in mmHg

Timeframe: Baseline

Systolic and Diastolic blood pressure in mmHg

Timeframe: 30 days

Systolic and Diastolic blood pressure in mmHg

Timeframe: 60 days

Systolic and Diastolic blood pressure in mmHg

Timeframe: 90 days

Body composition and body fat percentage

Timeframe: Baseline

Body composition and body fat percentage

Timeframe: 30 days

Body composition and body fat percentage

Timeframe: 60 days

Body composition and body fat percentage

Trial details

NCT IDNCT06978504

SponsorNutrindo Ideais Research Center

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Nutrition trials

Plain-language summary

Who can participate

Age range

40 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Systolic and Diastolic blood pressure in mmHg

Timeframe: Baseline

Systolic and Diastolic blood pressure in mmHg

Timeframe: 30 days

Systolic and Diastolic blood pressure in mmHg

Timeframe: 60 days

Systolic and Diastolic blood pressure in mmHg

Timeframe: 90 days

Body composition and body fat percentage

Timeframe: Baseline

Body composition and body fat percentage

Timeframe: 30 days

Body composition and body fat percentage

Timeframe: 60 days

Body composition and body fat percentage