Mediterranean Diet- and Psychological Well-being Theory-based Intervention to Reverse Metabolic Syndrome in Chile (CHILEMED)
Metabolic Syndrome
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Mediterranean diet, Psychological well-being
Eligibility Criteria
Inclusion Criteria:
Adult men or women 25-70 years-old with existing metabolic syndrome defined as the presence of at least three of the following criteria: (i) abdominal obesity (waist circumference >90 cm in men or >80 cm in women), (ii) low HDL-cholesterol (<40 mg/dl in men or <50 mg/dl in women) or under HDL increasing drugs, (iii) high triglycerides (TG) (≥ 150 mg/dl) or under TG lowering drugs, (iv) high blood hypertension (blood pressure ≥ 130/85 mmHg) or under treatment, and (v) high blood glucose (fasting plasma glucose concentration ≥ 100 mg/dl) or under treatment.
Exclusion Criteria:
- Absence of written informed consent
- Inability/low chance of adherence to diets or attend scheduled visits
- Allergy or intolerance to foods included in either interventional diets
- Recent (<12 months) participation in weight loss program
- Obesity with BMI >35 kg/m2 or due to endocrine diseases, with exception of treated hypothyroidism
- Type 1 diabetes, unstable type 2 diabetes
- Uncontrolled high blood pressure
- Previous clinical atherosclerotic cardiovascular disease
- Use of medications such as weight loss drugs, oral corticoids, immunosuppressants or cytotoxic agents
- Advanced chronic liver disease
- Previous organ transplantation
- History of HIV-positive status or AIDS
- History of inflammatory bowel disease or major gastrointestinal surgery (bariatric surgery, bowel resection)
- Active psychiatric conditions: eating disorders, severe depression, bipolar disorder, schizophrenia
- Short (<2 years) life expectancy
- Current or previous (within the last year) participation in other clinical trials with dietary or drug interventions
- Institutionalized subjects
- Additional conditions that may limit adherence to the study
Sites / Locations
- Pontificia Universidad Católica de Chile
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Low fat diet
Mediterranean diet alone
Mediterranean diet plus psychological well-being support
The low fat diet group will be counseled to consume a dietary pattern with fat restriction including food intake based in the pre-specified nutritional criteria.
The Mediterranean group will receive indications to consume a locally adapted and feasible dietary pattern including characteristic Mediterranean foods based on Chilean food availability.
The Mediterranean diet + well-being intervention group will be subject to intake a locally adapted and feasible pattern of Mediterranean foods available in Chile in combination with a psychological well-being theory-based intervention.