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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04019730
Other study ID # NL6540408118
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2018
Est. completion date October 10, 2019

Study information

Verified date July 2019
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 10, 2019
Est. primary completion date July 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Division of Human Nutrition, Wageningen University Wageningen Gelderland
Netherlands Wageningen University and research Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 stress hormone Cortisol blood samples will be collected before and after exercise, the level of cortisol will be estimated in these blood samples after 2 days and 2 weeks of adapted diet
Secondary ketone bodies in urine will be detected with KetoStix after 2 days and 2 weeks of adapted diet
Secondary Free fatty acids in blood will be detected with an ELISA after 2 days and 2 weeks of adapted diet
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