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

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Other: diet

• Registration Number: NCT04019730
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-07-06
• Study Start: 2018-10-10
• Status Verified: 2019-07
• Primary Completion: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-15
• Study Completion: 2019-10-10
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low carbohydrate diet	diet	less than 10 En% carbohydrates
high carbohydrate diet	diet	more than 50 En%carbohydrates

Primary Outcome Measures

Name	Time	Method
PBMC cell differentiation changes in %	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 Outcome Measures

Name	Time	Method
stress hormone Cortisol	after 2 days and 2 weeks of adapted diet	blood samples will be collected before and after exercise, the level of cortisol will be estimated in these blood samples
ketone bodies	after 2 days and 2 weeks of adapted diet	in urine will be detected with KetoStix
Free fatty acids	after 2 days and 2 weeks of adapted diet	in blood will be detected with an ELISA

Trial Locations

Locations (2)

Wageningen University and research; 🇳🇱 Wageningen, Gelderland, Netherlands

Division of Human Nutrition, Wageningen University; 🇳🇱 Wageningen, Gelderland, Netherlands