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

Primary Purpose

Cardiometabolic Syndrome

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vegan diet
Mediterranean diet
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiometabolic Syndrome focused on measuring Plant-Based Diet, Environmental Impact, Cardiorespiratory Fitness, Performance, Metabolic Health, Mediterranean diet, Vegan diet

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Francisco de Vitoria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vegan diet

Mediterranean diet

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2023
Last Updated
August 18, 2023
Sponsor
Universidad Francisco de Vitoria
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1. Study Identification

Unique Protocol Identification Number
NCT06008886
Brief Title
Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
August 28, 2023 (Anticipated)
Study Completion Date
September 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Francisco de Vitoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome
Keywords
Plant-Based Diet, Environmental Impact, Cardiorespiratory Fitness, Performance, Metabolic Health, Mediterranean diet, Vegan diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegan diet
Arm Type
Experimental
Arm Description
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)
Arm Title
Mediterranean diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vegan diet
Intervention Description
Normocaloric diet based solely on foods of plant sources.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet
Intervention Description
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 Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).
Time Frame
4 weeks
Title
Metabolic health
Description
Metabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)
Time Frame
4 weeks
Title
Performance
Description
Performance was measured using FATmax (g/min).
Time Frame
4 weeks
Title
Performance
Description
Performance was measured using countermovement (CMJ) (W) and squat jump (SJ).
Time Frame
4 weeks
Title
Performance
Description
Performance was measured using squat jump (SJ) (W)
Time Frame
4 weeks
Title
Environmental impact assessment
Description
Environmental impact was measured using Global-warming potential-100
Time Frame
4 weeks
Title
Inmune status
Description
Inmune status was measured using lymphocyte levels (109/L )
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Performance
Description
Performance was measured using handgrip
Time Frame
4 weeks
Title
Metabolic health
Description
Metabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Time Frame
4 weeks
Title
Inmune status
Description
Inmune status was measured using monocyte, eosinophils and neutrophils levels (10^9/L)
Time Frame
4 weeks
Title
Environmental impact assessment
Description
Environmental impact was measured using blue water footprint and land use.
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel López Moreno, Phd
Organizational Affiliation
Universidad Francisco de Vitoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Francisco de Vitoria University
City
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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