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

Sponsor

Universidad Francisco de Vitoria (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06008886

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiometabolic Syndrome	Behavioral: Vegan diet Behavioral: Mediterranean diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 19, 2023

Anticipated Primary Completion Date :

Aug 28, 2023

Anticipated Study Completion Date :

Sep 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vegan diet 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)	Behavioral: Vegan diet Normocaloric diet based solely on foods of plant sources.
Active Comparator: Mediterranean diet 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Vegan diet

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)

Behavioral: Vegan diet

Normocaloric diet based solely on foods of plant sources.

Active Comparator: Mediterranean diet

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Cardiorespiratory fitness [4 weeks]
Cardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).
Metabolic health [4 weeks]
Metabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)
Performance [4 weeks]
Performance was measured using FATmax (g/min).
Performance [4 weeks]
Performance was measured using countermovement (CMJ) (W) and squat jump (SJ).
Performance [4 weeks]
Performance was measured using squat jump (SJ) (W)
Environmental impact assessment [4 weeks]
Environmental impact was measured using Global-warming potential-100
Inmune status [4 weeks]
Inmune status was measured using lymphocyte levels (109/L )

Secondary Outcome Measures

Performance [4 weeks]
Performance was measured using handgrip
Metabolic health [4 weeks]
Metabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Inmune status [4 weeks]
Inmune status was measured using monocyte, eosinophils and neutrophils levels (10^9/L)
Environmental impact assessment [4 weeks]
Environmental impact was measured using blue water footprint and land use.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts 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.