Impact of a Mediterranean Diet on Cardiovascular Disease Risk Factors

NCT06113484 | Unknown

• 1 other identifier: 22/2023/CEFCM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Risk

Keywords

Cardiovascular disease; Risk factors; Mediterranean Diet; Plant-based Diet

Outcome Measures

Primary Outcomes (6)

• Body weight (kg)

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

  Day 1

• Body weight (kg)

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

  Day 90

• Body fat (%)

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

  Day 1

• Body fat (%)

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

  Day 90

• Waist circumference (cm)

  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)

  Day 1

• Waist circumference (cm)

  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)

  Day 90

Secondary Outcomes (28)

• Lipid profile

  Day 1

• Lipid profile

  Day 90

• Hemoglobin A1c

  Day 1

• Hemoglobin A1c

  Day 90

• C-reactive protein

  Day 1

Study Arms (3)

DIET + EXERCISE

EXPERIMENTAL

This group engages in physical exercise plus a nutritional intervention. Monthly individual nutrition consultations are conducted. Additionally, this group also benefits from a group culinary workshop.

Other: DIET + EXERCISE

WITHOUT DIET + EXERCISE

OTHER

This group engages in physical exercise; however, it is not the target of the nutritional intervention. Only a group educational session is conducted.

Other: WITHOUT DIET + EXERCISE

WITHOUT DIET + WHITOUT EXERCISE (CONTROL)

NO INTERVENTION

This group does not engage in physical exercise, nor is it the target of the nutritional intervention. Only a group educational session is conducted.

Interventions

DIET + EXERCISE OTHER

At first, a two-hour group session titled 'Discovering New Flavors' is conducted. This session aims to promote the consumption of healthy foods that should be included in the participants' daily diet. In order to create a different dynamic and enhance interaction, some recipe suggestions are prepared in a group setting. The intervention group is advised to have three (breakfast, lunch, and dinner) to four (breakfast, lunch, afternoon snack, and dinner) daily meals. Participants are encouraged not to count calories, thus emphasizing the importance of moderation. Regarding the main meals, legumes are recommended as a protein source for dinner. On the other hand, for lunch, the protein component can include white meats, fish, or eggs. Red and/or processed meats are excluded in this intervention. Moreover, all participants in this group are encouraged to practice a nightly fasting period of at least 12 hours.

DIET + EXERCISE

WITHOUT DIET + EXERCISE OTHER

An educational session titled "Healthy Eating: Nutritional Recommendations for Individuals at Risk of Cardiovascular Disease" will be conducted in a group setting. The objective of this session is to raise awareness among participants about the importance of a healthy diet and lifestyle in the prevention of cardiovascular diseases.

WITHOUT DIET + EXERCISE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Católica Portuguesa: lead
• Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv: collaborator

Study Sites (1)

Universidade Católica Portuguesa

Porto, Portugal

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Diet; Exercise

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: June 30, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

PT (1)