The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2018
CompletedStudy Start
First participant enrolled
October 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedDecember 19, 2019
July 1, 2019
9 months
July 6, 2018
December 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
after 2 days and 2 weeks of adapted diet
Secondary Outcomes (3)
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
Study Arms (2)
low carbohydrate diet
EXPERIMENTALless than 10 En% carbohydrates
high carbohydrate diet
EXPERIMENTALmore than 50 En%carbohydrates
Interventions
low carbohydrate diet (\< 10 EN% carbs) vs high carbohydrate diet (\>50 EN% carbs)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA, Netherlands
Wageningen University and research
Wageningen, Gelderland, 6708 WE, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marco Mensink, Dr
Wageningen University and Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2018
First Posted
July 15, 2019
Study Start
October 10, 2018
Primary Completion
July 10, 2019
Study Completion
October 10, 2019
Last Updated
December 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share