What this trial studies
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.
Conditions in scope
- Nutrition
- Metabolic Syndrome
- Obesity
- Weight Loss
- Genetic Polymorphisms
Interventions
- 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…
Who can join
Women only · Ages 40 Years to 60 Years · Accepts healthy volunteers.
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.
- 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.
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Rio de Janeiro | Nutrindo Ideais Research Center | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2025-04-01
- Primary completion: 2025-08-01
- Last update posted: 2025-05-18
- First posted: 2025-05-18
Sponsor & contact
Lead sponsor: Nutrindo Ideais Research Center (Network)
Collaborators: Universidade Federal do Rio de Janeiro
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Systolic and Diastolic blood pressure in mmHg (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. - Systolic and Diastolic blood pressure in mmHg (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. - Systolic and Diastolic blood pressure in mmHg (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. - Systolic and Diastolic blood pressure in mmHg (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. - Body composition and body fat percentage (Baseline)
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Related ClearedRx care
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Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06978504 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.