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

• Sponsor: Wageningen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04019730
• Collaborator: (none)
• Enrollment: 14
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site: 7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infections	Other: diet	N/A

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
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: Jul 10, 2019
• Actual Study Completion Date: Oct 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low carbohydrate diet less than 10 En% carbohydrates	Other: diet; low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)
Experimental: high carbohydrate diet more than 50 En%carbohydrates	Other: diet; low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. ketone bodies [after 2 days and 2 weeks of adapted diet]

   in urine will be detected with KetoStix

3. Free fatty acids [after 2 days and 2 weeks of adapted diet]

   in blood will be detected with an ELISA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Human Nutrition, Wageningen University	Wageningen	Gelderland	Netherlands	6703 HA
2	Wageningen University and research	Wageningen	Gelderland	Netherlands	6708 WE

Sponsors and Collaborators

• Wageningen University

Investigators

• Study Director: Marco Mensink, Dr, Wageningen University and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wageningen University
• ClinicalTrials.gov Identifier: NCT04019730
• Other Study ID Numbers: NL6540408118
• First Posted: Jul 15, 2019
• Last Update Posted: Dec 19, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Tract Infections

Study Results

No Results Posted as of Dec 19, 2019