NCT04078971

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

August 29, 2019

Last Update Submit

September 4, 2019

Conditions

Keywords

ketogenic dietwestern dietsoccersport performancemuscle massbody composition

Outcome Measures

Primary Outcomes (4)

  • Fat body mass

    Body composition with DEXA: we measure body fat mass in grams.

    4 weeks

  • lean body mass

    Body composition with DEXA: we measure lean body mass in grams.

    4 weeks

  • Visceral Adipose tissue (VAT)

    Body composition with DEXA: VAT in grams

    4 weeks

  • Total body water

    We will use a BIA to calculate totally body water and intracellular and extracellular water in liters

    4 weeks

Secondary Outcomes (8)

  • resting energy expenditure (REE)

    4 weeks

  • respiratory ratio (RR)

    4 weeks

  • specific performance

    4 weeks

  • lower limb power

    4 weeks

  • quadriceps muscle area

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

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

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%.

Other: Western diet

Interventions

Subjects in this intervention will follow a normal western diet

Western diet

Subjects in this group will follow a low carbohydrate ketogenic diet

Ketogenic diet

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • semiprofessional soccer players
  • male

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

Related Publications (4)

  • 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.

    PMID: 27803969BACKGROUND
  • 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.

    PMID: 25906427BACKGROUND
  • 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.

    PMID: 22835211BACKGROUND
  • 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.

MeSH Terms

Interventions

Diet, WesternDiet, Ketogenic

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeutics

Study Officials

  • Antonio Paoli, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Treatment and control were masked with A and B
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: It is single blind, parallel arms study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 6, 2019

Study Start

May 2, 2018

Primary Completion

October 30, 2018

Study Completion

December 15, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Raw data of outcomes on request

Locations