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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04078971
Other study ID # KDsoccer
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2018
Est. completion date December 15, 2018

Study information

Verified date September 2019
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The investigators will investigate the influence of a KD on different parameters in soccer players


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 15, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Western diet
Subjects in this intervention will follow a normal western diet
ketogenic diet
Subjects in this group will follow a low carbohydrate ketogenic diet

Locations

Country Name City State
Italy Nutrition and Exercise Lab, DSB, University of Padova Padova

Sponsors (1)

Lead Sponsor Collaborator
Antonio Paoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fat body mass Body composition with DEXA: we measure body fat mass in grams. 4 weeks
Primary lean body mass Body composition with DEXA: we measure lean body mass in grams. 4 weeks
Primary Visceral Adipose tissue (VAT) Body composition with DEXA: VAT in grams 4 weeks
Primary Total body water We will use a BIA to calculate totally body water and intracellular and extracellular water in liters 4 weeks
Secondary resting energy expenditure (REE) Measured through gas analyzer in ml/02/kg min 4 weeks
Secondary respiratory ratio (RR) Measured through gas analyses (ratio between CO2 and O2) 4 weeks
Secondary specific performance Yoyo intermittent recovery test level 1: in seconds 4 weeks
Secondary lower limb power squat jump test: height of the jump in cm 4 weeks
Secondary quadriceps muscle area muscle area measured in cm2 through ultrasound 4 weeks
Secondary quadriceps muscle thickness muscle thickness measured cm through ultrasound 4 weeks
Secondary quadriceps strength isometric contraction measured in N, the normalized per muscle area (N x cm2) 4 weeks
Secondary quadriceps strength per area the strength of isometric contraction (outcome 10) normalized per muscle area (Outcome 7). Expressed as (N x cm2) 4 weeks
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