NCT03691558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

May 15, 2018

Last Update Submit

September 29, 2018

Conditions

Ketogenic DietingPhysical Activity

Keywords

ketogenic diettriathlonVO2maxPPO

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • VO2 per Kg/bw

    after 5 weeks

  • VO2max

    after 5 weeks

  • Body composition LBM

    after 5 weeks

  • Body composition FM

    after 5 weeks

  • Body Weight

    after 5 weeks

Study Arms (2)

Ketogenic diet

EXPERIMENTAL

Subjects followed 5 weeks of ketogenic diet

Other: Ketogenic diet

Western Diet

ACTIVE COMPARATOR

Subjects followed 5 weeks of a western diet

Other: Western Diet

Interventions

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

Ketogenic diet
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

Western Diet

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • recent (less than 6 months) musculoskeletal injuries
  • more than 2 months without training in the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

Related Publications (8)

  • 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.

    PMID: 29619799BACKGROUND

  • 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.

    PMID: 29463034BACKGROUND

  • 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.

    PMID: 29108901BACKGROUND

  • 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.

    PMID: 28706467BACKGROUND

  • 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.

    PMID: 28012184BACKGROUND

  • 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.

    PMID: 22835211BACKGROUND

  • 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.

    PMID: 26892521BACKGROUND

  • 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.

    PMID: 23801097BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Diet, KetogenicDiet, Western

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Antonio Paoli, MD

    DSB University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Treatment and control were masked with A and B
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: It is single blind, parallel arms study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

October 1, 2018

Study Start

February 1, 2017

Primary Completion

April 25, 2017

Study Completion

July 12, 2017

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)