Metabolic Syndrome Clinical Trial
— CHILEMEDOfficial title:
Design, Implementation, and Prospective Evaluation of a Mediterranean Diet- and Psychological Well-being Theory-based Intervention to Reverse Metabolic Syndrome, a Highly Prevalent Chronic Disease Risk Condition in Chile
Verified date | May 2022 |
Source | Pontificia Universidad Catolica de Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Promotion of MedDiet adherence and psychological well-being in Chile offers a great potential to confront our ongoing epidemiological transition to increased risk factors and non-communicable chronic diseases. The main aims of this clinical trial are to design, implement, and evaluate the impact of a MedDiet- and psychological well-being-based intervention on reversal rate of MetS -compared to a control low fat diet- in Chilean adult population.
Status | Enrolling by invitation |
Enrollment | 339 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Chile | Pontificia Universidad Católica de Chile | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
Dussaillant C, Echeverría G, Urquiaga I, Velasco N, Rigotti A. [Current evidence on health benefits of the mediterranean diet]. Rev Med Chil. 2016 Aug;144(8):1044-1052. Review. Spanish. — View Citation
Echeverría G, Dussaillant C, McGee EE, Mena C, Nitsche MP, Urquiaga I, Bitran M, Pedrals N, Rigotti A. Promoting and Implementing the Mediterranean Diet in the Southern Hemisphere: the Chilean Experience. Eur J Clin Nutr. 2019 Jul;72(Suppl 1):38-46. doi: 10.1038/s41430-018-0307-7. Review. — View Citation
Echeverría G, McGee EE, Urquiaga I, Jiménez P, D'Acuña S, Villarroel L, Velasco N, Leighton F, Rigotti A. Inverse Associations between a Locally Validated Mediterranean Diet Index, Overweight/Obesity, and Metabolic Syndrome in Chilean Adults. Nutrients. 2017 Aug 11;9(8). pii: E862. doi: 10.3390/nu9080862. — View Citation
Echeverría G, Tiboni O, Berkowitz L, Pinto V, Samith B, von Schultzendorff A, Pedrals N, Bitran M, Ruini C, Ryff CD, Del Rio D, Rigotti A. Mediterranean Lifestyle to Promote Physical, Mental, and Environmental Health: The Case of Chile. Int J Environ Res Public Health. 2020 Nov 16;17(22). pii: E8482. doi: 10.3390/ijerph17228482. Review. — View Citation
Echeverría G, Urquiaga I, Concha MJ, Dussaillant C, Villarroel L, Velasco N, Leighton F, Rigotti A. [Validation of self-applicable questionnaire for a Mediterranean dietary index in Chile]. Rev Med Chil. 2016 Dec;144(12):1531-1543. doi: 10.4067/S0034-98872016001200004. Spanish. — View Citation
Figueroa C, Echeverría G, Villarreal G, Martínez X, Ferreccio C, Rigotti A. Introducing Plant-Based Mediterranean Diet as a Lifestyle Medicine Approach in Latin America: Opportunities Within the Chilean Context. Front Nutr. 2021 Jun 25;8:680452. doi: 10.3389/fnut.2021.680452. eCollection 2021. Review. — View Citation
Urquiaga I, Echeverría G, Dussaillant C, Rigotti A. [Origin, components and mechanisms of action of the Mediterranean diet]. Rev Med Chil. 2017 Jan;145(1):85-95. doi: 10.4067/S0034-98872017000100012. Review. Spanish. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolic syndrome | Metabolic syndrome is diagnosed when three out of five criteria from the NCEP ATPIII definition are present. The nutritional interventions will determine metabolic syndrome reversal when participants exhibit from 0 to 2 diagnostic criteria at the end of the study. | Month 12 | |
Secondary | Mediterranean Dietary adherence | Diet adherence to this food intake pattern will be assessed by the Chilean Mediterranean dietary index. Change in adherence to this diet will be evaluated as modification in the score (ranging from 0 to 14 points) during the interventions. Higher scores mean a better outcome. | Month 6 and 12 | |
Secondary | Insulin Resistance | Insulin resistance will be assessed through the HOMA-IR index obtained by measuring fasting glucose (mg/dL) and fasting insulin (uU/mL). | Month 6 and 12 | |
Secondary | Glucose homeostasis | Overall glucose homeostasis will be evaluated by measuring glycated hemoglobin (HbA1c) | Month 6 and 12 | |
Secondary | Lipid profile | Fasting triglycerides, total cholesterol, and HDL-cholesterol (all expressed as mg/dL) will be assessed to categorize lipid changes. | Month 6 and 12 | |
Secondary | High sensitivity C-reactive protein | High sensitivity C-reactive protein will be determined as pro-inflammatory and prognostic biomarker. | Month 6 and 12 | |
Secondary | Plasma antioxidant capacity | Ferric reducing ability of plasma (FRAP) in fasting plasma samples of participants will be used to assess total plasma antioxidant activity. | Month 6 and 12 | |
Secondary | Lipid peroxidation | Oxidized low-density lipoprotein (oxLDL) will be measured as lipid peroxidation biomarker | Month 6 and 12 | |
Secondary | Serum protein oxidation | Advanced oxidation protein products (AOPP) will be measured in serum samples as a biomarker of oxidative stress in proteins. | Month 6 and 12 | |
Secondary | Body mass index (BMI) | BMI will be calculated using weight and height in order to define the nutritional status of the patients | Month 6 and 12 | |
Secondary | Abdominal obesity | Abdominal/central obesity will be evaluated by measuring waist circumference | Month 6 and 12 | |
Secondary | Blood pressure control | Systolic/diastolic blood pressures will be assessed. | Month 6 and 12 | |
Secondary | Type 2 diabetes mellitus | Type 2 diabetes mellitus will be assessed based on ADA definitions, including fasting glycemia = 126 mg/dl, 2-h glycemia = 200 mg/dl after glucose challenge, HbA1C =6.5%, or patient with hyperglycemic symptoms and random glycemia = 200 mg/dl. | Month 6 and 12 | |
Secondary | Psychological well-being | The Ryff's multidimensional questionnaire/scale will be used to assess psychological well-being levels. Change in well-being will be evaluated as modification in the overall scale score (from 29 to 174 points) during the interventions. Higher scores means a better psychological well-being outcome. | Month 6 and 12 | |
Secondary | Positive mental health | Mental Health Continuum-short form questionnaire will be applied to assess positive emotional, psychological, and social well-being | Month 6 and 12 | |
Secondary | Emotional affectivity | Positive and Negative Affect Schedule survey will evaluate emotional affectivity | Month 6 and 12 | |
Secondary | Life, quality of | Quality of life will be assessed using the health-related quality of life (HRQoL) multidimensional SF-36 questionnaire. This questionnaire evaluates 8 dimensions using specific scales, each one ranging from 0 to 100 points. Higher scores indicate better quality of life. | Month 6 and 12 | |
Secondary | Psychological illness | Psychological illness will be assessed using the DASS-21 self-reported questionnaire. This questionnaire includes depression, anxiety and stress scales, each one ranging from 0 to 21 points. Higher scores indicate worse psychological illness. | Month 6 and 12 |
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