Mediterranean Diet- and Psychological Well-being Theory-based Intervention to Reverse Metabolic Syndrome in Chile

NCT05454904 | Unknown

• 2 other identifiers: 1906060131201607
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Mediterranean diet; Psychological well-being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Mediterranean Dietary adherence

  Month 6 and 12

• Insulin Resistance

  Month 6 and 12

• Glucose homeostasis

  Month 6 and 12

• Lipid profile

  Month 6 and 12

• High sensitivity C-reactive protein

  Month 6 and 12

Study Arms (3)

Low fat diet

ACTIVE COMPARATOR

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.

Behavioral: Low fat diet

Mediterranean diet alone

ACTIVE COMPARATOR

The Mediterranean group will receive indications to consume a locally adapted and feasible dietary pattern including characteristic Mediterranean foods based on Chilean food availability.

Behavioral: Mediterranean diet

Mediterranean diet plus psychological well-being support

ACTIVE COMPARATOR

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.

Behavioral: Mediterranean diet; Behavioral: Mediterranean diet plus psychological well-being support

Interventions

Low fat diet BEHAVIORAL

The low fat diet group will be counseled to consume a dietary pattern with fat restriction including food intake based in the following criteria: 1) \<3 teaspoons/day of olive or Canola oil and \<3 units/week of avocado, 2) removal of visible fat from meats before cooking or from cooked dishes before intake, 3) ≤1 serving per week fat-rich meats, hamburger, commercial ground meat, sausage, cured ham, bacon and salami, 4) daily consumption of low fat dairy products, 5) ≤1 serving/week of butter, margarine, lard, mayonnaise, milk cream, or milk- based ice cream, 6) ≤1 time/week intake of fatty fish or seafood, 7) ≤1 serving per week of commercial sweets or industrial bakery products (not homemade), and 8) ≤1 time/week consumption of nuts (including peanuts), potato chips, French fries, or commercial snacks. This intervention arm will be supplemented with powdered low fat milk (3 kgs/month) for daily use.

Low fat diet

Mediterranean diet BEHAVIORAL

The Mediterranean diet group will receive dietary recommendations as follows: 1) use of olive oil (\>3 teaspoons/day), 2) Canola oil as second fat source for cooking and dressing or \>3 units/week of avocado; 3) ≥3 daily servings of vegetables (at least one of them as fresh vegetables in a salad), 4) ≥2 daily servings of fresh fruits; 5) ≥2 weekly servings of legumes; 6) \>2 weekly servings of fresh, canned or frozen fish (at least one serving of oily fish)/seafood; 7) ≥2 weekly servings of nuts/seeds; 8) 4-8 servings/week of white meats (poultry or turkey without skin) instead of 9) fatty or processed meats (\<1 serving/week), 10) ≥2 daily servings of whole grains, 11) ≥1 daily/serving of low fat and fermented dairy products, 12) \<1 daily/serving of whole fat dairy products, 13) ≤1 daily/serving of sugary snacks, drinks or juices and \<4 teaspoons/daily of sugar, and 14) moderate (1-2 drinks/day) wine consumption with meals.

Mediterranean diet alone; Mediterranean diet plus psychological well-being support

Mediterranean diet plus psychological well-being support BEHAVIORAL

This group will be subjected to the same Mediterranean diet pattern indicated previously as well as to a psychological well-being intervention that will include a variety of components/activities, embracing values, purpose, self-acceptance, character strengths, emotional regulation, dealing with negativity, goal-setting, mindfulness, savoring, gratitude, autonomy, relationships, social interactions, and prosocial behavior.

Mediterranean diet plus psychological well-being support

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8331150, Chile

Location

Related Publications (7)

• Dussaillant C, Echeverria 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. doi: 10.4067/S0034-98872016000800012. Spanish.

  PMID: 27905651 BACKGROUND

• Echeverria 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.

  PMID: 28393987 BACKGROUND

• Urquiaga I, Echeverria 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. Spanish.

  PMID: 28393974 BACKGROUND

• Echeverria G, McGee EE, Urquiaga I, Jimenez P, D'Acuna 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):862. doi: 10.3390/nu9080862.

  PMID: 28800091 BACKGROUND

• Echeverria 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.

  PMID: 30487560 BACKGROUND

• Echeverria 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):8482. doi: 10.3390/ijerph17228482.

  PMID: 33207718 BACKGROUND

• Figueroa C, Echeverria G, Villarreal G, Martinez 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.

  PMID: 34249989 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Psychological Well-Being

Interventions

Diet, Fat-Restricted; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Plant-Based

Study Officials

• Attilio Rigotti

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three parallel-group randomized controlled clinical trial

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: July 12, 2022
• Study Start: March 15, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)