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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04019730
Recruitment Status : Active, not recruiting
First Posted : July 15, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Wageningen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Other: diet Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low carbohydrate diet
less than 10 En% carbohydrates
Other: diet
low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)

Experimental: high carbohydrate diet
more than 50 En%carbohydrates
Other: diet
low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019730


Locations
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Netherlands
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, Netherlands, 6703 HA
Wageningen University and research
Wageningen, Gelderland, Netherlands, 6708 WE
Sponsors and Collaborators
Wageningen University
Investigators
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Study Director: Marco Mensink, Dr Wageningen University and Research

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT04019730     History of Changes
Other Study ID Numbers: NL6540408118
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases