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

Sponsor

Antonio Paoli (Other)

Overall Status

Completed

CT.gov ID

NCT04078971

Collaborator

(none)

Enrollment

Location

Arms

7.5

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Athletic Performance	Other: Western diet Other: ketogenic diet	N/A

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

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

It is single blind, parallel arms studyIt 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

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

Actual Study Start Date :

May 2, 2018

Actual Primary Completion Date :

Oct 30, 2018

Actual Study Completion Date :

Dec 15, 2018

Arms and Interventions

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	Other: ketogenic diet 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%.	Other: Western diet Subjects in this intervention will follow a normal western diet

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

Other: ketogenic diet

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%.

Other: Western diet

Subjects in this intervention will follow a normal western diet

Outcome Measures

Primary Outcome Measures

Fat body mass [4 weeks]
Body composition with DEXA: we measure body fat mass in grams.
lean body mass [4 weeks]
Body composition with DEXA: we measure lean body mass in grams.
Visceral Adipose tissue (VAT) [4 weeks]
Body composition with DEXA: VAT in grams
Total body water [4 weeks]
We will use a BIA to calculate totally body water and intracellular and extracellular water in liters

Secondary Outcome Measures

resting energy expenditure (REE) [4 weeks]
Measured through gas analyzer in ml/02/kg min
respiratory ratio (RR) [4 weeks]
Measured through gas analyses (ratio between CO2 and O2)
specific performance [4 weeks]
Yoyo intermittent recovery test level 1: in seconds
lower limb power [4 weeks]
squat jump test: height of the jump in cm
quadriceps muscle area [4 weeks]
muscle area measured in cm2 through ultrasound
quadriceps muscle thickness [4 weeks]
muscle thickness measured cm through ultrasound
quadriceps strength [4 weeks]
isometric contraction measured in N, the normalized per muscle area (N x cm2)
quadriceps strength per area [4 weeks]
the strength of isometric contraction (outcome 10) normalized per muscle area (Outcome 7). Expressed as (N x cm2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.