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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03691558
Other study ID # KDTRI17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date July 12, 2017

Study information

Verified date September 2018
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to verify the effects of 5 weeks of ketogenic diet (KD) on some performance index in long distance triathletes


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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 12, 2017
Est. primary completion date April 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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
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

Locations

Country Name City State
Italy Nutrition and Exercise Lab, DSB, University of Padova Padova

Sponsors (3)

Lead Sponsor Collaborator
University of Padova Universidade Federal de Goias, University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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). pii: E236. doi: 10.3390/nu10020236. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Eur J Clin Nutr. 2014 May;68(5):641. — View Citation

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. — View Citation

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. 2018 Apr 4. doi: 10.23736/S0022-4707.18.08318-4. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 after 5 weeks
Secondary VO2 per Kg/bw VO2 measured as ml O2 per kilograms of body weight after 5 weeks
Secondary VO2max Maximal oxygen consumption measured through a incremental bike test after 5 weeks
Secondary Body composition LBM Lean body mass (Kg) measured by Body Impedence Analysis after 5 weeks
Secondary Body composition FM Fat mass (Kg) measured by Body Impedence Analysis after 5 weeks
Secondary Body Weight in Kg after 5 weeks
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