Athletic PerformanceNCT04078971
Effects of Ketogenic Diet on Body Composition and Performance in Soccer Players
A study testing Western diet and ketogenic diet in people with Athletic Performance, run by Antonio Paoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Western diet and ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2018to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- semiprofessional soccer players
- male
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Athletic Performance
- Being tested
- Western diet, ketogenic diet
- Keywords
- ketogenic diet, western diet, soccer, sport performance, muscle mass, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western dietOther
Subjects in this intervention will follow a normal western diet
ketogenic dietOther
Subjects in this group will follow a low carbohydrate ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | 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 Receives: Other: ketogenic diet |
| Western diet | Active comparator | 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%. Receives: Other: Western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat body mass
Body composition with DEXA: we measure body fat mass in grams.
Measured: 4 weeks
lean body mass
Body composition with DEXA: we measure lean body mass in grams.
Measured: 4 weeks
Visceral Adipose tissue (VAT)
Body composition with DEXA: VAT in grams
Measured: 4 weeks
Total body water
We will use a BIA to calculate totally body water and intracellular and extracellular water in liters
Measured: 4 weeks
Secondary outcomes (8)
resting energy expenditure (REE)
Measured through gas analyzer in ml/02/kg min
Measured: 4 weeks
respiratory ratio (RR)
Measured through gas analyses (ratio between CO2 and O2)
Measured: 4 weeks
specific performance
Yoyo intermittent recovery test level 1: in seconds
Measured: 4 weeks
lower limb power
squat jump test: height of the jump in cm
Measured: 4 weeks
quadriceps muscle area
muscle area measured in cm2 through ultrasound
Measured: 4 weeks
quadriceps muscle thickness
muscle thickness measured cm through ultrasound
Measured: 4 weeks
quadriceps strength
isometric contraction measured in N, the normalized per muscle area (N x cm2)
Measured: 4 weeks
quadriceps strength per area
the strength of isometric contraction (outcome 10) normalized per muscle area (Outcome 7). Expressed as (N x cm2)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start2 May 2018
- Primary completion30 Oct 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is single blind, parallel arms study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Paoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Paoli, University of Padova
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078971
- Sponsor's protocol ID
- KDsoccer
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Raw data of outcomes on request
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.
PubMed 27803969Paoli 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.
PubMed 25906427Paoli 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.
PubMed 22835211Antonio 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.
PubMed 34530857
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Very Low Carbohydrate Ketogenic Diet on Body Composition, Muscle Strength, Muscle Area, Metabolism and Performance in Semi-professional Soccer Players
- ClinicalTrials.gov ID
- NCT04078971
- Acronym / sponsor ID
- KDsoccer
- Conditions
- Athletic Performance
- Keywords
- ketogenic diet, western diet, soccer, sport performance, muscle mass, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Antonio PaoliUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is single blind, parallel arms study
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Other: ketogenic dietKetogenic 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 |
| Western diet | Active comparator | Other: Western dietThe 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%. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- semiprofessional soccer players
- male
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Western dietSubjects in this intervention will follow a normal western diet | Other | Western diet |
| ketogenic dietSubjects in this group will follow a low carbohydrate ketogenic diet | Other | Ketogenic diet |
Primary outcome
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
8 secondary outcomes
resting energy expenditure (REE)
Time frame: 4 weeks
respiratory ratio (RR)
Time frame: 4 weeks
specific performance
Time frame: 4 weeks
lower limb power
Time frame: 4 weeks
quadriceps muscle area
Time frame: 4 weeks
quadriceps muscle thickness
Time frame: 4 weeks
quadriceps strength
Time frame: 4 weeks
quadriceps strength per area
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 27803969Rubini 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.
- Background: PubMed 25906427Paoli 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.
- Background: PubMed 22835211Paoli 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.
- Derived from this study: PubMed 34530857Antonio 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.
- Individual participant dataSharing planned: No. Raw data of outcomes on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Paoli, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western diet and ketogenic diet in people with Athletic Performance, run by Antonio Paoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat body mass (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078971, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.