Upper Respiratory Tract InfectionsNCT04019730
The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
A study testing diet in people with Upper Respiratory Tract Infections, run by Wageningen University at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesNetherlands
- Study dates
- 10 Oct 2018to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA
Wageningen University and research
Wageningen, Gelderland, 6708 WE
About this study
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.
Read the 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.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- diet
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietOther
low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)
| Study group | Role | What they receive |
|---|---|---|
| low carbohydrate diet | Experimental | less than 10 En% carbohydrates Receives: Other: diet |
| high carbohydrate diet | Experimental | more than 50 En%carbohydrates Receives: Other: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 2 days and 2 weeks of adapted diet
Secondary outcomes (3)
stress hormone Cortisol
blood samples will be collected before and after exercise, the level of cortisol will be estimated in these blood samples
Measured: after 2 days and 2 weeks of adapted diet
ketone bodies
in urine will be detected with KetoStix
Measured: after 2 days and 2 weeks of adapted diet
Free fatty acids
in blood will be detected with an ELISA
Measured: after 2 days and 2 weeks of adapted diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start10 Oct 2018
- Primary completion10 Jul 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Mensink, Dr, Study director, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019730
- Sponsor's protocol ID
- NL6540408118
- Status last verified
- Jul 2019
- First submitted
- 6 Jul 2018
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
- ClinicalTrials.gov ID
- NCT04019730
- Acronym / sponsor ID
- NL6540408118
- Conditions
- Upper Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low carbohydrate diet | Experimental | Other: dietless than 10 En% carbohydrates |
| high carbohydrate diet | Experimental | Other: dietmore than 50 En%carbohydrates |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietlow carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs) | Other | high carbohydrate diet, low carbohydrate diet |
Primary outcome
PBMC cell differentiation changes in %
Time frame: 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.
3 secondary outcomes
stress hormone Cortisol
Time frame: after 2 days and 2 weeks of adapted diet
ketone bodies
Time frame: after 2 days and 2 weeks of adapted diet
Free fatty acids
Time frame: after 2 days and 2 weeks of adapted diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Mensink, Dr study director
Wageningen University and Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet in people with Upper Respiratory Tract Infections, run by Wageningen University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PBMC cell differentiation changes in % (time frame: after 2 days and 2 weeks of adapted diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.