Effects of the DASH diet and genetics on weight loss in menopausal women with metabolic syndrome
What is the Impact of Genetic Polymorphisms and DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome?
This study is testing how the DASH diet and certain genes affect weight loss and health in menopausal women with metabolic syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Nutrindo Ideais Research Center Research network |
| Locations | 1 site (Rio de Janeiro) |
| Trial ID | NCT06978504 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how genetic variations in the FTO and ADRB2 genes interact with the DASH diet to influence weight loss and metabolic health in menopausal women aged 40 to 60 with metabolic syndrome. Participants will receive personalized dietary plans and undergo regular consultations with a nutritionist over a 90-day period. The study will collect anthropometric data and laboratory tests to assess changes in health indicators related to obesity and metabolic syndrome. The goal is to understand the combined effects of diet and genetics on weight loss progression and metabolic improvement.
Who should consider this trial
Good fit: Ideal candidates are menopausal women aged 40 to 60 years with obesity (BMI > 30) and diagnosed with metabolic syndrome.
Not a fit: Patients with a BMI less than 25 or those with chronic diseases that interfere with diet adherence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into personalized dietary interventions that enhance weight loss and metabolic health in menopausal women.
How similar studies have performed: While there is limited research on the specific interaction of the DASH diet and genetic polymorphisms in this population, similar dietary interventions have shown promise in improving metabolic health.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rio de Janeiro
- Nutrindo Ideais Research Center — Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Study coordinator: Guilherme Renke, MD MSc
- Email: renke@renke.com.br
- Phone: +552197695-9339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.