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Effects of Ketogenic Diet on Body Composition and Performance in Soccer Players

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ClinicalTrials.gov Identifier: NCT04078971
Recruitment Status : Completed
First Posted : September 5, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Paoli, University of Padova

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 5, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE May 2, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • Fat body mass [ Time Frame: 4 weeks ]
    Body composition with DEXA: we measure body fat mass in grams.
  • lean body mass [ Time Frame: 4 weeks ]
    Body composition with DEXA: we measure lean body mass in grams.
  • Visceral Adipose tissue (VAT) [ Time Frame: 4 weeks ]
    Body composition with DEXA: VAT in grams
  • Total body water [ Time Frame: 4 weeks ]
    We will use a BIA to calculate totally body water and intracellular and extracellular water in liters
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
  • Body composition: Fat body mass, lean body mass and visceral adipose tissue [ Time Frame: 4 weeks ]
    Body composition with DEXA: we measure body fat mass, lean body mass and visceral Adipose tissue in grams.
  • Total body water [ Time Frame: 4 weeks ]
    We will use a BIA to calculate totally body water and intracellular and extracellular water in liters
Change History Complete list of historical versions of study NCT04078971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
  • resting energy expenditure (REE) [ Time Frame: 4 weeks ]
    Measured through gas analyzer in ml/02/kg min
  • respiratory ratio (RR) [ Time Frame: 4 weeks ]
    Measured through gas analyses (ratio between CO2 and O2)
  • specific performance [ Time Frame: 4 weeks ]
    Yoyo intermittent recovery test level 1: in seconds
  • lower limb power [ Time Frame: 4 weeks ]
    squat jump test: height of the jump in cm
  • quadriceps muscle area [ Time Frame: 4 weeks ]
    muscle area measured in cm2 through ultrasound
  • quadriceps muscle thickness [ Time Frame: 4 weeks ]
    muscle thickness measured cm through ultrasound
  • quadriceps strength [ Time Frame: 4 weeks ]
    isometric contraction measured in N, the normalized per muscle area (N x cm2)
  • quadriceps strength per area [ Time Frame: 4 weeks ]
    the strength of isometric contraction (outcome 10) normalized per muscle area (Outcome 7). Expressed as (N x cm2)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ketogenic Diet on Body Composition and Performance in Soccer Players
Official Title  ICMJE Effects of a Very Low Carbohydrate Ketogenic Diet on Body Composition, Muscle Strength, Muscle Area, Metabolism and Performance in Semi-professional Soccer Players
Brief Summary A ketogenic diet (KD) is a nutritional approach, usually adopted for weight loss, that restricts daily carbohydrates under 30 g/day. KD showed contradictory results on sport performance, whilst no data are available on team sports. The investigators will investigate the influence of a KD on different parameters in soccer players
Detailed Description Sixteen semi-professional soccer players will be randomly assigned to a ketogenic diet (KD n=8) or to a western diet (WD n=8). Diets contain the same amount of protein (1.8g/Kg body weight/day). Body weight and body composition will be measured by dual energy x-ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA). Resting energy expenditure (REE), respiratory exchange ratio (RER), cross sectional area (CSA) and isometric muscle strength of quadriceps, counter movement jump (CMJ) and yoyo intermittent recovery test will be measured.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
It is single blind, parallel arms study
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Treatment and control were masked with A and B
Primary Purpose: Basic Science
Condition  ICMJE Athletic Performance
Intervention  ICMJE
  • Other: Western diet
    Subjects in this intervention will follow a normal western diet
  • Other: ketogenic diet
    Subjects in this group will follow a low carbohydrate ketogenic diet
Study Arms  ICMJE
  • Experimental: Ketogenic diet
    Ketogenic diet: less than 30 g/day of carbohydrate. Subjects can eat beef, veal, poultry, fish, raw and cooked vegetables without restriction, cold cuts such as dried beef, eggs and seasoned cheese (parmesan), ketogenic pasta (selected with a ketogenic ratio of 4:1), fruits with the lowest glycemic index (blueberry, raspberry), raw nuts and seeds, ghee butter, plant oils and fats from avocado, coconut and olives
    Intervention: Other: ketogenic diet
  • Active Comparator: Western diet
    The western diet (WD) is composed mainly of whole cereals (spelt, rye, oat) and pseudo-cereals (buckwheat, quinoa, amaranth), whole grain pasta, potatoes, meet, fish, vegetables, fruit, legumes, olive oil, milk and red wine (at most 1 glass per day). It ensure a constant energy and macronutrient balance: protein 1.8g x Kg-1 x body weight-1 x day-1, (30%), fats 20-25% and carbohydrate 50-55%.
    Intervention: Other: Western diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2019)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • semiprofessional soccer players
  • male

Exclusion Criteria:

  • body fat percentage over 32%, (determined via dual energy X-ray absorptiometry DEXA),
  • cardiovascular,
  • respiratory, gastrointestinal,
  • thyroid or any other metabolic diseases,
  • weight change more than 2 Kg over the last month,
  • adherence to special diets,
  • use of nutritional supplements (except a daily multivitamin-mineral)
  • use of medication to control blood lipids or glucose and goal-keepers.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04078971
Other Study ID Numbers  ICMJE KDsoccer
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Raw data of outcomes on request
Responsible Party Antonio Paoli, University of Padova
Study Sponsor  ICMJE Antonio Paoli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Paoli, MD University of Padova
PRS Account University of Padova
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP