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

Upper Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019730
• Other study ID #: NL6540408118
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

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