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Clinical Trials/NCT04019730
NCT04019730CompletedNot Applicable

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

Wageningen University4 sites in 1 country14 target enrollmentStarted: October 10, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
4
Primary Endpoint
PBMC cell differentiation changes in %

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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