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

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

Sponsors

Lead Sponsor: Wageningen University

Source 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.

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.

Overall Status Completed
Start Date October 10, 2018
Completion Date October 10, 2019
Primary Completion Date July 10, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
PBMC cell differentiation changes in % after 2 days and 2 weeks of adapted diet
Secondary Outcome
Measure Time Frame
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
Enrollment 14
Condition
Intervention

Intervention Type: Other

Intervention Name: diet

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

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Marco Mensink, Dr Study Director Wageningen University and Research
Location
Facility:
Division of Human Nutrition, Wageningen University | Wageningen, Gelderland, 6703 HA, Netherlands
Wageningen University and research | Wageningen, Gelderland, 6708 WE, Netherlands
Location Countries

Netherlands

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: low carbohydrate diet

Type: Experimental

Description: less than 10 En% carbohydrates

Label: high carbohydrate diet

Type: Experimental

Description: more than 50 En%carbohydrates

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Single (Participant)

Source: ClinicalTrials.gov