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临床试验/NCT04019730
NCT04019730已完成不适用

The Effect of a Ketogenic Diet on the Exercise Induced Immune Response

Wageningen University4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
4
主要终点
PBMC cell differentiation changes in %

研究概览

简要总结

comparing the exercise induced immune response after two weeks on a low carbohydrate (ketogenic) diet with the response after two weeks on a high carbohydrate diet.

详细描述

A cross-over intervention study, with a total duration of 6 weeks. An athlete follows a high, or low carbohydrate (ketogenic) diet. After 2 days a test day takes place where the athlete performs an exercise test and blood samples are taken at different time points. After that, the athlete continues following the diet for another 12 days, after which he comes back again for another identical test day. Then a 2 weeks wash-out period. After that, the athlete follows the same protocol but then with either the low (ketogenic), or high carbohydrate diet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 18 - 45 y
  • BMI: 18.5 - 25 kg/m2
  • Hb ≥ 8.5 mmol/L, determined with blood sample from finger tip
  • Minimal of 3 hours of training per week, and a maximum of 10 hours
  • DKTP (diphtheria, pertussis, tetanus and polio) vaccinated (for stimulation of isolated cells (PBMC's) with tetanus toxoid)
  • No asthma medication and/or anti-inflammatory medication
  • No use of immunosuppressive medication
  • No flu and/or travel vaccinations in the 4 months before and during the study
  • Able to be present and participate at all test days
  • Willing and able to follow prescribed 2 times a diet for 2 weeks in a row

排除标准

  • Chronic illness
  • Food allergies (e.g. nuts, gluten, avocado)
  • Vegetarian diet
  • Blood donations during study or in the 2 months prior to the study
  • Use of immunosuppressive medication
  • Flu and/or travel vaccination 4 months before and during the study
  • Hb < 8.5 mmol/L
  • Working at "Human Nutrition" - Wageningen University

结局指标

主要结局

PBMC cell differentiation changes in %

时间窗: after 2 days and 2 weeks of adapted diet

blood samples will be collected before and after exercise, the % of T-cells, NK-T-cells, B-cells, Monocytes in blood will be estimated with flow cytometrie.

次要结局

  • stress hormone Cortisol(after 2 days and 2 weeks of adapted diet)
  • ketone bodies(after 2 days and 2 weeks of adapted diet)
  • Free fatty acids(after 2 days and 2 weeks of adapted diet)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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