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Clinical Trials/NCT06113484
NCT06113484Active, not recruitingNot Applicable

Impact of a Mediterranean Diet (gReenheArTediEt - RATE) on Cardiovascular Disease Risk Factors: a Randomized Clinical Trial.

Universidade Católica Portuguesa1 site in 1 country90 target enrollmentStarted: June 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
90
Locations
1
Primary Endpoint
Waist circumference (cm)

Study Overview

Brief Summary

This approved and funded research project is part of a larger project titled "Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR): personalized exercise protocol in the rehabilitation after acute myocardial infarction or at risk of cardiovascular disease and knee osteoarthritis, a multicenter clinical intervention study".

The main objective of this work is to quantify the effect of a nutritional and physical activity intervention in improving important risk factors for cardiovascular disease, such as body weight, body composition, and waist circumference.

Detailed Description

Cardiovascular diseases are the leading cause of death worldwide and one of the main contributors to diminished quality of life. It is estimated that in the year 2019, approximately 17.9 million individuals died due to this non-communicable disease, accounting for 32% of all global deaths. It is considered that CVDs result from the interaction between genetic predisposition (non-modifiable risk factors) and environmental influences (modifiable risk factors). Environmental factors prevail over others and often lead to negative outcomes through the adoption of poor lifestyles, such as imbalanced nutrition, physical inactivity, smoking, and alcohol habits. These are considered risk factors with direct effects on the pathogenesis of CVDs, and indirectly contribute to increasing the risk for predisposition to chronic diseases such as hypertension, dyslipidemia, overweight, obesity, and diabetes mellitus.

Currently, scientific literature has demonstrated the importance of diet in preventing CVDs and how it can minimize their risk factors. The Dietary Approaches to Stop Hypertension, Mediterranean dietary pattern, vegetarian diet, EAT-Lancet diet, and other dietary strategies have been published in various scientific journals.

Parallel to health, another topic that has gained prominence in the scientific community is environmental degradation derived from current food production. With the projected population growth until 2050, reaching 10 billion, the effects of food production on greenhouse gas emissions, nitrogen and phosphorus pollution, biodiversity loss, and water and land use are predicted to reach such high values that they will lead to the destabilization of the Earth system.

Considering that diet holds both environmental value and promotes cardiovascular health, this study aims to explore more sustainable and health-promoting dietary adaptations. This intervention will be based on principles of the Mediterranean diet, integrating higher consumption of plant sources compared to other mentioned patterns, and also leveraging the benefits of chronobiology, which are important for weight and adiposity control.

RECRUITMENT PLAN Participants will be recruited from the Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR) project, carried out under the Algarve Biomedical Center - Research Institute. After the participants are integrated into the A3-COR project, those who meet the requirement of never having suffered from AMI but have high cardiovascular disease risk criteria according to the SCORE2 or SCORE2 O.P. algorithm will be contacted by phone. At this point, the objective of the nutritional intervention and the necessary conditions for participation will be explained (assessment of the remaining inclusion and exclusion criteria). After verifying these criteria, they will be invited to voluntarily participate in the present study. Those who accept to join the study will be contacted again to schedule the initial evaluation, and must sign the informed consent form prior to that.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age equal to or greater than 50 years
  • Individuals meeting the criteria for high cardiovascular disease risk in the SCORE2 or SCORE2 O.P algorithm
  • Autonomy in activities of daily living
  • Provide informed and clarified consent

Exclusion Criteria

  • Occurrence of Acute Myocardial Infarction (AMI)
  • To receive nutritional counseling from a registered dietitian
  • To follow a vegetarian or strict vegetarian dietary pattern
  • To take nutritional supplementation

Outcomes

Primary Outcomes

Waist circumference (cm)

Time Frame: Day 90

The abdominal circumference is assessed using a measuring tape at the midpoint between the upper edge of the iliac crest and the last palpable rib, following the methodology established by ISAK (International Society for the Advancement of Kinanthropometry)

Body weight (kg)

Time Frame: Day 90

Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions

Body fat (%)

Time Frame: Day 90

Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.

Secondary Outcomes

  • Fragility(Day 90)
  • Hemoglobin A1c(Day 90)
  • Arm circumference(Day 90)
  • Lean body mass(Day 90)
  • C-reactive protein(Day 90)
  • Hand grip strength(Day 90)
  • Food diary(Day 90)
  • Cardiovascular Risk(Day 90)
  • Arm muscle area(Day 90)
  • Lipid profile(Day 90)
  • Sarcopenia(Day 90)
  • Bicep Skinfold(Day 90)
  • Tricep Skinfold(Day 90)
  • Legume intake(Day 90)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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