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临床试验/NCT06008886
NCT06008886已完成不适用

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

Universidad Francisco de Vitoria2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Cardiorespiratory fitness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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/m
  • No tobacco use.
  • No or low alcohol consumption and no orthopedic limitations that would interfere with the performance of the study tests.

排除标准

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

结局指标

主要结局

Cardiorespiratory fitness

时间窗: 4 weeks

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

Environmental impact assessment

时间窗: 4 weeks

Environmental impact was measured using Global-warming potential-100

Inmune status

时间窗: 4 weeks

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

Metabolic health

时间窗: 4 weeks

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

Performance

时间窗: 4 weeks

Performance was measured using FATmax (g/min).

次要结局

  • Environmental impact assessment(4 weeks)
  • Inmune status(4 weeks)
  • Performance(4 weeks)
  • Metabolic health(4 weeks)

研究者

发起方
Universidad Francisco de Vitoria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel López Moreno

Principal Investigator

Universidad Francisco de Vitoria

研究点 (2)

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