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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06008886
Acronym
OMNIVEG
Enrollment
14
Registered
2023-08-24
Start date
2023-06-19
Completion date
2023-09-04
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Syndrome

Keywords

Plant-Based Diet, Environmental Impact, Cardiorespiratory Fitness, Performance, Metabolic Health, Mediterranean diet, Vegan diet

Brief 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.

Interventions

BEHAVIORALVegan diet

Normocaloric diet based solely on foods of plant sources.

BEHAVIORALMediterranean diet

Diet 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.

Sponsors

Universidad Francisco de Vitoria
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Inmune status4 weeksInmune status was measured using lymphocyte levels (109/L )
Cardiorespiratory fitness4 weeksCardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).
Metabolic health4 weeksMetabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)
Performance4 weeksPerformance was measured using FATmax (g/min).
Environmental impact assessment4 weeksEnvironmental impact was measured using Global-warming potential-100

Secondary

MeasureTime frameDescription
Metabolic health4 weeksMetabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Inmune status4 weeksInmune status was measured using monocyte, eosinophils and neutrophils levels (10\^9/L)
Environmental impact assessment4 weeksEnvironmental impact was measured using blue water footprint and land use.
Performance4 weeksPerformance was measured using handgrip

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026