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

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6703 HA
      • Division of Human Nutrition, Wageningen University
    • Wageningen, Gelderland, Netherlands, 6708 WE
      • Wageningen University and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ketone bodies	in urine will be detected with KetoStix	after 2 days and 2 weeks of adapted diet
Free fatty acids	in blood will be detected with an ELISA	after 2 days and 2 weeks of adapted diet

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: NL6540408118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No