Effects of Ketogenic Diet in Body Builders | NCT04629365

Studies
Effects of Ketogenic Diet in Body Builders

NCT04629365

Sponsor

University of Padova

Status

Completed

Last Update Posted

Nov 17, 2020Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Diet, Healthy
Body Weight

Interventions

Ketogenic Diet
Normal Diet

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Oct 31, 2020Actual

First Submitted Date

Nov 9, 2020

First Submission Date that Met QC Criteria

Nov 9, 2020

First Posted Date

Nov 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2020

Last Update Posted Date

Nov 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the study sought to investigate the influence of 8 weeks of a very low carbohydrate ketogenic diet on body composition, muscle strength, muscle area and blood parameters in competitive natural body builders.

Detailed Description

nineteen natural body builders were randomly assigned to a ketogenic diet (KD) group or to a normal diet group (ND) with a traditional meal pattern. The two diets were isocaloric and included the same amount of protein per kg of body weight; but differed in the distribution of fats and carbohydrates; the latter were kept below 5% daily (less than 50g/day) in the KD group while represented 55% of the caloric intake in the WD group During the experimental period, training loads were similar in the two groups. Athletes were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, muscle strength and blood parameters were measured.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketogenic Diet	Experimental	KD group consumed less than 50g/day of carbohydrates	Other: Ketogenic Diet
Normal Diet	Active Comparator	ND group consumed 55% of the caloric intake from carbohydrates	Other: Normal Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketogenic Diet	Other	KD group consumed less than 50g/day of carbohydrates	Ketogenic Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fat Mass	fat mass measured through body impedence analyser	8 weeks
Lean Body Mass	lean body mass mass measured through body impedence analyser	8 weeks
Maximal muscle strength	muscle strength measured via 1-RM test	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
blood glucose	glucose as milligram per deciliter	8 weeks
testosterone	Testosterone free as picogram per milliliter	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 5 years of training experiences
competing in recognized body building category

Exclusion Criteria:

adherence to special diets
use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
use of medications (steroids)
diabetes or metabolic diseases

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio Paoli, MD	University of Padova	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nutrition and Exercise Lab, DSB, University of Padova		Padova		35131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001835	Body Weight

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055423	Diet, Ketogenic

Ancestor Terms

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided