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Completed

NCT Number: NCT06008886

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Francisco de Vitoria University

Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vegan diet

Behavioral

Normocaloric diet based solely on foods of plant sources.

Mediterranean Diet

Behavioral

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.

Primary outcomes

  1. Cardiorespiratory fitness

    Time frame: 4 weeks

    Cardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).

  2. Metabolic health

    Time frame: 4 weeks

    Metabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)

  3. Performance

    Time frame: 4 weeks

    Performance was measured using FATmax (g/min).

  4. Performance

    Time frame: 4 weeks

    Performance was measured using countermovement (CMJ) (W) and squat jump (SJ).

  5. Performance

    Time frame: 4 weeks

    Performance was measured using squat jump (SJ) (W)

  6. Environmental impact assessment

    Time frame: 4 weeks

    Environmental impact was measured using Global-warming potential-100

  7. Inmune status

    Time frame: 4 weeks

    Inmune status was measured using lymphocyte levels (109/L )

Secondary outcomes

  1. Performance

    Time frame: 4 weeks

    Performance was measured using handgrip

  2. Metabolic health

    Time frame: 4 weeks

    Metabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).

  3. Inmune status

    Time frame: 4 weeks

    Inmune status was measured using monocyte, eosinophils and neutrophils levels (10^9/L)

  4. Environmental impact assessment

    Time frame: 4 weeks

    Environmental impact was measured using blue water footprint and land use.

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

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

Acronym: OMNIVEG

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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