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

Cardiometabolic Syndrome Clinical Trial

— OMNIVEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06008886
• Other study ID #: 20/2023
• Status: Completed
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: September 4, 2023

Study information

• Verified date: August 2023
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 4, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome

Intervention

Behavioral:
• Vegan diet
Normocaloric diet based solely on foods of plant sources.
• Mediterranean 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.

Locations

Country	Name	City	State
Spain	Francisco de Vitoria University	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness	Cardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).	4 weeks
Primary	Metabolic health	Metabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)	4 weeks
Primary	Performance	Performance was measured using FATmax (g/min).	4 weeks
Primary	Performance	Performance was measured using countermovement (CMJ) (W) and squat jump (SJ).	4 weeks
Primary	Performance	Performance was measured using squat jump (SJ) (W)	4 weeks
Primary	Environmental impact assessment	Environmental impact was measured using Global-warming potential-100	4 weeks
Primary	Inmune status	Inmune status was measured using lymphocyte levels (109/L )	4 weeks
Secondary	Performance	Performance was measured using handgrip	4 weeks
Secondary	Metabolic health	Metabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).	4 weeks
Secondary	Inmune status	Inmune status was measured using monocyte, eosinophils and neutrophils levels (10^9/L)	4 weeks
Secondary	Environmental impact assessment	Environmental impact was measured using blue water footprint and land use.	4 weeks