- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691558
Effects of Ketogenic Diet on Triathlon's Performance
September 29, 2018 updated by: Antonio Paoli, University of Padova
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Padova, Italy, 35131
- Nutrition and Exercise Lab, DSB, University of Padova
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- recent (less than 6 months) musculoskeletal injuries
- more than 2 months without training in the last 2 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic diet
Subjects followed 5 weeks of ketogenic diet
|
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
|
Active Comparator: Western Diet
Subjects followed 5 weeks of a western diet
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
after 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 per Kg/bw
Time Frame: after 5 weeks
|
VO2 measured as ml O2 per kilograms of body weight
|
after 5 weeks
|
VO2max
Time Frame: after 5 weeks
|
Maximal oxygen consumption measured through a incremental bike test
|
after 5 weeks
|
Body composition LBM
Time Frame: after 5 weeks
|
Lean body mass (Kg) measured by Body Impedence Analysis
|
after 5 weeks
|
Body composition FM
Time Frame: after 5 weeks
|
Fat mass (Kg) measured by Body Impedence Analysis
|
after 5 weeks
|
Body Weight
Time Frame: after 5 weeks
|
in Kg
|
after 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonio Paoli, MD, DSB University of Padova
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Paoli 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.
- Paoli 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. Erratum In: Eur J Clin Nutr. 2014 May;68(5):641.
- Volek 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.
- Burke 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.
- 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.
- Carr 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.
- McSwiney 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.
- Zinn 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
April 25, 2017
Study Completion (Actual)
July 12, 2017
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 1, 2018
Study Record Updates
Last Update Posted (Actual)
October 2, 2018
Last Update Submitted That Met QC Criteria
September 29, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KDTRI17
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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