- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078971
Effects of Ketogenic Diet on Body Composition and Performance in Soccer Players
September 4, 2019 updated by: Antonio Paoli
Effects of a Very Low Carbohydrate Ketogenic Diet on Body Composition, Muscle Strength, Muscle Area, Metabolism and Performance in Semi-professional Soccer Players
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Subjects in this group will follow a low carbohydrate 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%.
|
Subjects in this intervention will follow a normal western diet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat body mass
Time Frame: 4 weeks
|
Body composition with DEXA: we measure body fat mass in grams.
|
4 weeks
|
lean body mass
Time Frame: 4 weeks
|
Body composition with DEXA: we measure lean body mass in grams.
|
4 weeks
|
Visceral Adipose tissue (VAT)
Time Frame: 4 weeks
|
Body composition with DEXA: VAT in grams
|
4 weeks
|
Total body water
Time Frame: 4 weeks
|
We will use a BIA to calculate totally body water and intracellular and extracellular water in liters
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
resting energy expenditure (REE)
Time Frame: 4 weeks
|
Measured through gas analyzer in ml/02/kg min
|
4 weeks
|
respiratory ratio (RR)
Time Frame: 4 weeks
|
Measured through gas analyses (ratio between CO2 and O2)
|
4 weeks
|
specific performance
Time Frame: 4 weeks
|
Yoyo intermittent recovery test level 1: in seconds
|
4 weeks
|
lower limb power
Time Frame: 4 weeks
|
squat jump test: height of the jump in cm
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4 weeks
|
quadriceps muscle area
Time Frame: 4 weeks
|
muscle area measured in cm2 through ultrasound
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4 weeks
|
quadriceps muscle thickness
Time Frame: 4 weeks
|
muscle thickness measured cm through ultrasound
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4 weeks
|
quadriceps strength
Time Frame: 4 weeks
|
isometric contraction measured in N, the normalized per muscle area (N x cm2)
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4 weeks
|
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)
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Rubini A, Bosco G, Lodi A, Cenci L, Parmagnani A, Grimaldi K, Zhongjin Y, Paoli A. Erratum to: Effects of Twenty Days of the Ketogenic Diet on Metabolic and Respiratory Parameters in Healthy Subjects. Lung. 2017 Feb;195(1):155. doi: 10.1007/s00408-016-9958-0. No abstract available.
- Paoli A, Bianco A, Grimaldi KA. The Ketogenic Diet and Sport: A Possible Marriage? Exerc Sport Sci Rev. 2015 Jul;43(3):153-62. doi: 10.1249/JES.0000000000000050.
- 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.
- Antonio Paoli A, Mancin L, Caprio M, Monti E, Narici MV, Cenci L, Piccini F, Pincella M, Grigoletto D, Marcolin G. Effects of 30 days of ketogenic diet on body composition, muscle strength, muscle area, metabolism, and performance in semi-professional soccer players. J Int Soc Sports Nutr. 2021 Sep 16;18(1):62. doi: 10.1186/s12970-021-00459-9.
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)
May 2, 2018
Primary Completion (Actual)
October 30, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
August 29, 2019
First Submitted That Met QC Criteria
September 2, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Actual)
September 6, 2019
Last Update Submitted That Met QC Criteria
September 4, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- KDsoccer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Raw data of outcomes on request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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