Back to resultsThe Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Primary Purpose
Upper Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
diet
Sponsored by
About this trial
This is an interventional basic science trial for Upper Respiratory Tract Infections
Eligibility 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
Sites / Locations
- Division of Human Nutrition, Wageningen University
- Wageningen University and research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
low carbohydrate diet
high carbohydrate diet
Arm Description
less than 10 En% carbohydrates
more than 50 En%carbohydrates
Outcomes
Primary Outcome Measures
PBMC cell differentiation changes in %
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
stress hormone Cortisol
blood samples will be collected before and after exercise, the level of cortisol will be estimated in these blood samples
ketone bodies
in urine will be detected with KetoStix
Free fatty acids
in blood will be detected with an ELISA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04019730
Brief Title
The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Official Title
The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low carbohydrate diet
Arm Type
Experimental
Arm Description
less than 10 En% carbohydrates
Arm Title
high carbohydrate diet
Arm Type
Experimental
Arm Description
more than 50 En%carbohydrates
Intervention Type
Other
Intervention Name(s)
diet
Intervention Description
low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)
Primary Outcome Measure Information:
Title
PBMC cell differentiation changes in %
Description
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.
Time Frame
after 2 days and 2 weeks of adapted diet
Secondary Outcome Measure Information:
Title
stress hormone Cortisol
Description
blood samples will be collected before and after exercise, the level of cortisol will be estimated in these blood samples
Time Frame
after 2 days and 2 weeks of adapted diet
Title
ketone bodies
Description
in urine will be detected with KetoStix
Time Frame
after 2 days and 2 weeks of adapted diet
Title
Free fatty acids
Description
in blood will be detected with an ELISA
Time Frame
after 2 days and 2 weeks of adapted diet
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Mensink, Dr
Organizational Affiliation
Wageningen University and Research
Official's Role
Study Director
Facility Information:
Facility Name
Division of Human Nutrition, Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6703 HA
Country
Netherlands
Facility Name
Wageningen University and research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WE
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
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