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Completed

NCT Number: NCT04019730

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Division of Human Nutrition, Wageningen University, Wageningen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Diet

Other

low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)

Primary outcomes

  1. PBMC cell differentiation changes in %

    Time frame: 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.

Secondary outcomes

  1. stress hormone Cortisol

    Time frame: after 2 days and 2 weeks of adapted diet

    blood samples will be collected before and after exercise, the level of cortisol will be estimated in these blood samples

  2. ketone bodies

    Time frame: after 2 days and 2 weeks of adapted diet

    in urine will be detected with KetoStix

  3. Free fatty acids

    Time frame: after 2 days and 2 weeks of adapted diet

    in blood will be detected with an ELISA

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2019
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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