Ketogenic DietingNCT03691558
Effects of Ketogenic Diet on Triathlon's Performance
A study testing Ketogenic diet and Western Diet in people with Ketogenic Dieting and Physical Activity, run by University of Padova at 1 site in Italy.
Trial summary
The study aimed to verify the effects of 5 weeks of ketogenic diet (KD) on some performance index in long distance triathletes Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting, Physical Activity
- What is being tested?
- Ketogenic diet and Western Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 12 Jul 2017
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- long distance Triathletes (8-10 hours of training per week), competing in half Ironman or Ironman
- no previous experience of low carbohydrate diet
- more than 3 years of training
Who cannot join
- recent (less than 6 months) musculoskeletal injuries
- more than 2 months without training in the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Five Weeks of Ketogenic Diet on Long Distance Triathletes Performance
The study aimed to verify the effects of 5 weeks of ketogenic diet (KD) on some performance index in long distance triathletes
Read the detailed description
16 well trained male long distance Triathletes participates in the study (30.65 ± 10.77 years of age), with minimum one year of triathlon competition experience and 8-10 hours of training per week. All subjects had a personal interview made by a registered Medical Doctor about the diet intervention prior to the beginning of the study. Moreover participants were educated about the benefits and limitations of the two different dietary treatments and asked to nominate their preference for, or non-acceptance of, each of these interventions. Thus participants also decided liberally if participate for the diet intervention or not. This choice was decided to prevent any type of dropout in the KD group, considering that a free and conscious choices is better for the adherence on a strict diet like ketogenic diet . Investigators were thus able to allocate the athletes to their preferred treatment, while achieving suitable matching of groups based on age, body mass and aerobic power. All the participants were healthy and injured free, and not consuming a low carbs diet prior to the study. The diet macronutrient percentage distribution was the following: for ND the percentages were 25% of TDC (total daily calories), fat were 20% of TDC and carbohydrates represented the 55% of TDC; for KD the percentages were 68% fat, 26% protein and 6% carbohydrate. In the KD very low carbohydrate foods that simulate carbohydrates taste food like croissants, bread and cracked slices made by Le Gamberi Foods (Forlì, Italy), were used for a better compliance to the dietary intervention. Subjects undertaken an anthropometric test and two different cardiopulmonary tests with a professional cycloergometer (MARCA). The anthropometric measures were taken to evaluated body weight. height and body composition . After the body composition analysis subjects underwent to a maximal cardiopulmonary test (GXT) to evaluate the maximal oxygen consumption (VO2max). The following day subjects performed 60 minutes at 45% of PPO to assess endurance performance at ironman biking race-pace. The day after test session KD group started the KD 5 weeks. The Control Group (S) followed his habitual normo-caloric, balanced diet. The same order and procedures were conducted for testing the subjects post diet intervention. Anthropometric and performance test was conducted in the same order for each subjects and at the same time of the day. Blood ketones were measured each other day to ensure the compliance to KD
- Conditions
- Ketogenic Dieting, Physical Activity
- Being tested
- Ketogenic diet, Western Diet
- Keywords
- ketogenic diet, triathlon, VO2max, PPO
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
total daily caloric intake was divided into 5 meals. Individual daily caloric need is calculated referring to body composition and adjusted for daily activity (Frankenfield, Roth-Yousey, \& Compher, 2005; Wang et al., 2000). Macronutrients percentage is 68% fat, 26% protein and 6% carbohydrate Paoli et al. 2013). Very low carbohydrate foods that simulate carbohydrates taste food like croissants, bread and cracked slices made by Le Gamberi Foods (Forlì, Italy), are used for a better compliance to the dietary intervention
Western DietOther
total daily caloric intake was divided into 5 meals. Individual daily caloric need is calculated referring to body composition and adjusted for daily activity (Frankenfield, Roth-Yousey, \& Compher, 2005; Wang et al., 2000). The diet macronutrient percentage distribution is the following: protein is 25% of TDC (total daily calories), fat is 20% of TDC and carbohydrates represented the 55% of TDC
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Subjects followed 5 weeks of ketogenic diet Receives: Other: Ketogenic diet |
| Western Diet | Active comparator | Subjects followed 5 weeks of a western diet Receives: Other: Western Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 at 45% of peak power output
We measured the mean VO2 during one hour at the 45% of peak power output (PPO) measured during the first test
Measured: after 5 weeks
Secondary outcomes (5)
VO2 per Kg/bw
VO2 measured as ml O2 per kilograms of body weight
Measured: after 5 weeks
VO2max
Maximal oxygen consumption measured through a incremental bike test
Measured: after 5 weeks
Body composition LBM
Lean body mass (Kg) measured by Body Impedence Analysis
Measured: after 5 weeks
Body composition FM
Fat mass (Kg) measured by Body Impedence Analysis
Measured: after 5 weeks
Body Weight
in Kg
Measured: after 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Feb 2017
- Primary completion25 Apr 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ketogenic DietingStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It is single blind, parallel arms study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Goias, University of Palermo
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Antonio Paoli, MD, Principal investigator, DSB University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691558
- Sponsor's protocol ID
- KDTRI17
- Status last verified
- Sep 2018
- First submitted
- 15 May 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wroble KA, Trott MN, Schweitzer GG, Rahman RS, Kelly PV, Weiss EP. Low-carbohydrate, ketogenic diet impairs anaerobic exercise performance in exercise-trained women and men: a randomized-sequence crossover trial. J Sports Med Phys Fitness. 2019 Apr;59(4):600-607. doi: 10.23736/S0022-4707.18.08318-4. Epub 2018 Apr 4.
PubMed 29619799Carr AJ, Sharma AP, Ross ML, Welvaert M, Slater GJ, Burke LM. Chronic Ketogenic Low Carbohydrate High Fat Diet Has Minimal Effects on Acid-Base Status in Elite Athletes. Nutrients. 2018 Feb 18;10(2):236. doi: 10.3390/nu10020236.
PubMed 29463034McSwiney FT, Wardrop B, Hyde PN, Lafountain RA, Volek JS, Doyle L. Keto-adaptation enhances exercise performance and body composition responses to training in endurance athletes. Metabolism. 2018 Apr;81:25-34. doi: 10.1016/j.metabol.2017.10.010. Epub 2017 Nov 3.
PubMed 29108901Zinn C, Wood M, Williden M, Chatterton S, Maunder E. Ketogenic diet benefits body composition and well-being but not performance in a pilot case study of New Zealand endurance athletes. J Int Soc Sports Nutr. 2017 Jul 12;14:22. doi: 10.1186/s12970-017-0180-0. eCollection 2017.
PubMed 28706467Burke LM, Ross ML, Garvican-Lewis LA, Welvaert M, Heikura IA, Forbes SG, Mirtschin JG, Cato LE, Strobel N, Sharma AP, Hawley JA. Low carbohydrate, high fat diet impairs exercise economy and negates the performance benefit from intensified training in elite race walkers. J Physiol. 2017 May 1;595(9):2785-2807. doi: 10.1113/JP273230. Epub 2017 Feb 14.
PubMed 28012184Paoli A, Grimaldi K, D'Agostino D, Cenci L, Moro T, Bianco A, Palma A. Ketogenic diet does not affect strength performance in elite artistic gymnasts. J Int Soc Sports Nutr. 2012 Jul 26;9(1):34. doi: 10.1186/1550-2783-9-34.
PubMed 22835211Volek JS, Freidenreich DJ, Saenz C, Kunces LJ, Creighton BC, Bartley JM, Davitt PM, Munoz CX, Anderson JM, Maresh CM, Lee EC, Schuenke MD, Aerni G, Kraemer WJ, Phinney SD. Metabolic characteristics of keto-adapted ultra-endurance runners. Metabolism. 2016 Mar;65(3):100-10. doi: 10.1016/j.metabol.2015.10.028. Epub 2015 Nov 2.
PubMed 26892521Paoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26.
PubMed 23801097
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Five Weeks of Ketogenic Diet on Long Distance Triathletes Performance
- ClinicalTrials.gov ID
- NCT03691558
- Acronym / sponsor ID
- KDTRI17
- Conditions
- Ketogenic Dieting, Physical Activity
- Keywords
- ketogenic diet, triathlon, VO2max, PPO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Universidade Federal de Goias, University of Palermo
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 1 Oct 2018 (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.
The study aimed to verify the effects of 5 weeks of ketogenic diet (KD) on some performance index in long distance triathletes
Detailed description
16 well trained male long distance Triathletes participates in the study (30.65 ± 10.77 years of age), with minimum one year of triathlon competition experience and 8-10 hours of training per week. All subjects had a personal interview made by a registered Medical Doctor about the diet intervention prior to the beginning of the study. Moreover participants were educated about the benefits and limitations of the two different dietary treatments and asked to nominate their preference for, or non-acceptance of, each of these interventions. Thus participants also decided liberally if participate for the diet intervention or not. This choice was decided to prevent any type of dropout in the KD group, considering that a free and conscious choices is better for the adherence on a strict diet like ketogenic diet . Investigators were thus able to allocate the athletes to their preferred treatment, while achieving suitable matching of groups based on age, body mass and aerobic power. All the participants were healthy and injured free, and not consuming a low carbs diet prior to the study. The diet macronutrient percentage distribution was the following: for ND the percentages were 25% of TDC (total daily calories), fat were 20% of TDC and carbohydrates represented the 55% of TDC; for KD the percentages were 68% fat, 26% protein and 6% carbohydrate. In the KD very low carbohydrate foods that simulate carbohydrates taste food like croissants, bread and cracked slices made by Le Gamberi Foods (Forlì, Italy), were used for a better compliance to the dietary intervention. Subjects undertaken an anthropometric test and two different cardiopulmonary tests with a professional cycloergometer (MARCA). The anthropometric measures were taken to evaluated body weight. height and body composition . After the body composition analysis subjects underwent to a maximal cardiopulmonary test (GXT) to evaluate the maximal oxygen consumption (VO2max). The following day subjects performed 60 minutes at 45% of PPO to assess endurance performance at ironman biking race-pace. The day after test session KD group started the KD 5 weeks. The Control Group (S) followed his habitual normo-caloric, balanced diet. The same order and procedures were conducted for testing the subjects post diet intervention. Anthropometric and performance test was conducted in the same order for each subjects and at the same time of the day. Blood ketones were measured each other day to ensure the compliance to KD
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is single blind, parallel arms study
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Other: Ketogenic dietSubjects followed 5 weeks of ketogenic diet |
| Western Diet | Active comparator | Other: Western DietSubjects followed 5 weeks of a western diet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- long distance Triathletes (8-10 hours of training per week), competing in half Ironman or Ironman
- no previous experience of low carbohydrate diet
- more than 3 years of training
Key exclusion criteria (2 listed)
- recent (less than 6 months) musculoskeletal injuries
- more than 2 months without training in the last 2 years
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 |
|---|---|---|
| Ketogenic diettotal daily caloric intake was divided into 5 meals. Individual daily caloric need is calculated referring to body composition and adjusted for daily activity (Frankenfield, Roth-Yousey, \& Compher, 2005; Wang et al., 2000). Macronutrients percentage is 68% fat, 26% protein and 6% carbohydrate Paoli et al. 2013). Very low carbohydrate foods that simulate carbohydrates taste food like croissants, bread and cracked slices made by Le Gamberi Foods (Forlì, Italy), are used for a better compliance to the dietary intervention | Other | Ketogenic diet |
| Western Diettotal daily caloric intake was divided into 5 meals. Individual daily caloric need is calculated referring to body composition and adjusted for daily activity (Frankenfield, Roth-Yousey, \& Compher, 2005; Wang et al., 2000). The diet macronutrient percentage distribution is the following: protein is 25% of TDC (total daily calories), fat is 20% of TDC and carbohydrates represented the 55% of TDC | Other | Western Diet |
Primary outcome
VO2 at 45% of peak power output
Time frame: after 5 weeks
We measured the mean VO2 during one hour at the 45% of peak power output (PPO) measured during the first test
5 secondary outcomes
VO2 per Kg/bw
Time frame: after 5 weeks
VO2max
Time frame: after 5 weeks
Body composition LBM
Time frame: after 5 weeks
Body composition FM
Time frame: after 5 weeks
Body Weight
Time frame: after 5 weeks
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 2 Oct 2018.
- Background: PubMed 29619799Wroble KA, Trott MN, Schweitzer GG, Rahman RS, Kelly PV, Weiss EP. Low-carbohydrate, ketogenic diet impairs anaerobic exercise performance in exercise-trained women and men: a randomized-sequence crossover trial. J Sports Med Phys Fitness. 2019 Apr;59(4):600-607. doi: 10.23736/S0022-4707.18.08318-4. Epub 2018 Apr 4.
- Background: PubMed 29463034Carr AJ, Sharma AP, Ross ML, Welvaert M, Slater GJ, Burke LM. Chronic Ketogenic Low Carbohydrate High Fat Diet Has Minimal Effects on Acid-Base Status in Elite Athletes. Nutrients. 2018 Feb 18;10(2):236. doi: 10.3390/nu10020236.
- Background: PubMed 29108901McSwiney FT, Wardrop B, Hyde PN, Lafountain RA, Volek JS, Doyle L. Keto-adaptation enhances exercise performance and body composition responses to training in endurance athletes. Metabolism. 2018 Apr;81:25-34. doi: 10.1016/j.metabol.2017.10.010. Epub 2017 Nov 3.
- Background: PubMed 28706467Zinn C, Wood M, Williden M, Chatterton S, Maunder E. Ketogenic diet benefits body composition and well-being but not performance in a pilot case study of New Zealand endurance athletes. J Int Soc Sports Nutr. 2017 Jul 12;14:22. doi: 10.1186/s12970-017-0180-0. eCollection 2017.
- Background: PubMed 28012184Burke LM, Ross ML, Garvican-Lewis LA, Welvaert M, Heikura IA, Forbes SG, Mirtschin JG, Cato LE, Strobel N, Sharma AP, Hawley JA. Low carbohydrate, high fat diet impairs exercise economy and negates the performance benefit from intensified training in elite race walkers. J Physiol. 2017 May 1;595(9):2785-2807. doi: 10.1113/JP273230. Epub 2017 Feb 14.
- Background: PubMed 22835211Paoli A, Grimaldi K, D'Agostino D, Cenci L, Moro T, Bianco A, Palma A. Ketogenic diet does not affect strength performance in elite artistic gymnasts. J Int Soc Sports Nutr. 2012 Jul 26;9(1):34. doi: 10.1186/1550-2783-9-34.
- Background: PubMed 26892521Volek JS, Freidenreich DJ, Saenz C, Kunces LJ, Creighton BC, Bartley JM, Davitt PM, Munoz CX, Anderson JM, Maresh CM, Lee EC, Schuenke MD, Aerni G, Kraemer WJ, Phinney SD. Metabolic characteristics of keto-adapted ultra-endurance runners. Metabolism. 2016 Mar;65(3):100-10. doi: 10.1016/j.metabol.2015.10.028. Epub 2015 Nov 2.
- Background: PubMed 23801097Paoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26.
- 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.
Antonio Paoli, MD principal investigator
DSB University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and Western Diet in people with Ketogenic Dieting and Physical Activity, run by University of Padova at 1 site in Italy.
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 3 inclusion and 2 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
VO2 at 45% of peak power output (time frame: after 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691558, which also lists 8 linked publications.
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 2 Oct 2018.