Clinical Trials Directory

Trials / Completed

CompletedNCT06008886

Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes

Effect of a Vegan Diet Versus a Mediterrean Diet on Performance, Cardiorespiratory Fitness, Metabolic Health, Immune Status, and Environmental Impact in Healthy Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Universidad Francisco de Vitoria · Academic / Other
Sex
Male
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALVegan dietNormocaloric diet based solely on foods of plant sources.
BEHAVIORALMediterranean dietDiet with a predominance of plant foods fruits, vegetables, whole grains, nuts and legumes); 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.

Timeline

Start date
2023-06-19
Primary completion
2023-08-28
Completion
2023-09-04
First posted
2023-08-24
Last updated
2023-11-28

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06008886. Inclusion in this directory is not an endorsement.