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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ketogenic diet
Subjects followed 5 weeks of ketogenic diet
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
Active Comparator: Western Diet
Subjects followed 5 weeks of a western diet
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Palermo
Universidade Federal de Goias

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings