Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes (OMNIVEG)

Universidad Francisco de Vitoria

Status: Completed

Conditions: Cardiometabolic Syndrome

Treatments: Behavioral: Vegan diet; Behavioral: Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06008886

20/2023

Details and patient eligibility

About

This study aimed to evaluate the effect of a vegan diet (supplemented with vitamin B12) and an mediterranean diet on performance, cardiorespiratory fitness, metabolic health, immune status, and environmental impact in healthy adults.

Full description

OMNIVEG is a controlled crossover trial. Initially, registered dietitians conducted an assessment of participants' lifestyles in a preliminary session. Qualified nutritionists then developed personalized diets for each participant in accordance with the recommendations of the International Society of Sports Nutrition (ISSN). These diets followed specific guidelines, including a daily intake of 3-5 g of carbohydrates per kilogram of body weight, 1.4-2.0 g of protein per kilogram of body weight, and 0.5-1.5 g of fat per kilogram of body weight.

Both the mediterranean diet and vegan diets prescribed to the participants were isocaloric, with similar distributions of macronutrients. The primary difference between the two interventions was the source of food: the vegan diet exclusively comprised plant-based foods, while the omnivorous diet included foods of both animal and plant sources. In the case of the omnivorous diet, 60% of the total protein intake was derived from animal sources (mainly from fish, white meat, low-fat dairy and eggs).

As part of the vegan diet, participants were instructed to take 1000 µg of cyanocobalamin (a form of vitamin B12) twice a week from Harrison Sport Nutrition, Granada, Spain. This supplementation aimed to ensure adequate vitamin B12 intake, which is essential for individuals following a vegan diet.

Throughout the study period, participants were advised to maintain their initial physical exercise frequency and volume to maintain consistency and avoid confounding variables. To ensure standardized measurements, all tests were conducted in the same laboratory, employing identical testing devices, and supervised by the same group of researchers. This approach aimed to minimize experimental variability and improve the reliability of the study's results.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men.
• Aged between 18-40 years.
• Physically active according to the recommendations of the World Health Organization (WHO).
• Body Mass Index (BMI) between 18.5-24.9 kg/m2.
• No tobacco use.
• No or low alcohol consumption and no orthopedic limitations that would interfere with the performance of the study tests.

Exclusion criteria

• Chronic diseases that impair athletic performance (cardiovascular, metabolic, gastrointestinal, respiratory) within the last six months.
• Musculoskeletal disease within the last six months.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Vegan diet

Experimental group

Description:

Vegan diet all foods included were of plant sources. During the vegan diet, the participants took 1000 µg of cyanocobalamin twice a week (Harrison Sport Nutrition, Granada, Spain)

Treatment:

Behavioral: Vegan diet

Mediterranean diet

Active Comparator group

Description:

In the case of the mediterranean diet, foods of animal sources were also included (animal protein accounted for 60% of total protein intake). In this diet there was a predominance of plant foods; moderate to low consumption of fish, white meat, low-fat dairy and eggs; and very low consumption of red and processed meats, butter, full-fat dairy and sweets.

Treatment:

Behavioral: Mediterranean diet