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

NCT ID: NCT04019730

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-10-10

Brief Summary

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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

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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.

Conditions

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Upper Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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low carbohydrate diet

less than 10 En% carbohydrates

Group Type EXPERIMENTAL

diet

Intervention Type OTHER

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

high carbohydrate diet

more than 50 En%carbohydrates

Group Type EXPERIMENTAL

diet

Intervention Type OTHER

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

Interventions

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diet

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Mensink, Dr

Role: STUDY_DIRECTOR

Wageningen University and Research

Locations

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Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, Netherlands

Site Status

Wageningen University and research

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL6540408118

Identifier Type: -

Identifier Source: org_study_id