NCT06978504 Impact of Genetic Polymorphisms And DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome
| NCT ID | NCT06978504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutrindo Ideais Research Center |
| Condition | Nutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06978504 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 60 Years, studying Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06978504 currently recruiting?
Yes, NCT06978504 is actively recruiting participants. Contact the research team at renke@renke.com.br for enrollment information.
Where is the NCT06978504 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT06978504 clinical trial?
NCT06978504 is sponsored by Nutrindo Ideais Research Center. The trial plans to enroll 30 participants.