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

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

Interventions

BEHAVIORAL

Low fat diet

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.

BEHAVIORAL

Mediterranean diet

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.

BEHAVIORAL

Mediterranean diet plus psychological well-being support

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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile

  lead OTHER

Principal Investigators

• Attilio Rigotti · Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2024-03-31

Completion

2024-03-31

Countries

• Chile

Study Locations