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

NCT06008886 | Completed

• 1 other identifier: 20/2023
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Cardiorespiratory fitness

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

  4 weeks

• Metabolic health

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

  4 weeks

• Performance

  Performance was measured using FATmax (g/min).

  4 weeks

• Performance

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

  4 weeks

• Performance

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

  4 weeks

• Environmental impact assessment

  Environmental impact was measured using Global-warming potential-100

  4 weeks

• Inmune status

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

  4 weeks

Secondary Outcomes (4)

• Performance

  4 weeks

• Metabolic health

  4 weeks

• Inmune status

  4 weeks

• Environmental impact assessment

  4 weeks

Study Arms (2)

Vegan diet

EXPERIMENTAL

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

Mediterranean diet

ACTIVE COMPARATOR

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

Interventions

Vegan diet BEHAVIORAL

Normocaloric diet based solely on foods of plant sources.

Vegan diet

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.

Mediterranean diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Chronic diseases that impair athletic performance (cardiovascular, metabolic, gastrointestinal, respiratory) within the last six months.
• Musculoskeletal disease within the last six months.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

Study Sites (1)

Francisco de Vitoria University

Madrid, 28223, Spain

Location

Related Publications (2)

• Lopez-Moreno M, Fresan U, Del Coso J, Munoz A, Aguilar-Navarro M, Iglesias-Lopez MT, Amaro-Gahete FJ, Gutierrez-Hellin J. The OMNIVEG Study: Effects of Transitioning from a Traditional to a Vegan Mediterranean Diet on Fat Oxidation During Exercise. Nutrients. 2025 Jul 9;17(14):2274. doi: 10.3390/nu17142274.

  PMID: 40732902 DERIVED

• Lopez-Moreno M, Fresan U, Del Coso J, Aguilar-Navarro M, Iglesias Lopez MT, Pena-Fernandez J, Munoz A, Gutierrez-Hellin J. The OMNIVEG STUDY: Health outcomes of shifting from a traditional to a vegan Mediterranean diet in healthy men. A controlled crossover trial. Nutr Metab Cardiovasc Dis. 2024 Dec;34(12):2680-2689. doi: 10.1016/j.numecd.2024.08.008. Epub 2024 Aug 23.

  PMID: 39358106 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Vegan; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Miguel López Moreno, Phd

  Universidad Francisco de Vitoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 24, 2023
• Study Start: June 19, 2023
• Primary Completion: August 28, 2023
• Study Completion: September 4, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)