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Effects of Ketogenic Diet in Body Builders

Primary Purpose

Diet, Healthy, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ketogenic Diet
Normal Diet
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diet, Healthy focused on measuring ketogenic diet, body builders, athletes, body composition, hormones

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nutrition and Exercise Lab, DSB, University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketogenic Diet

Normal Diet

Arm Description

KD group consumed less than 50g/day of carbohydrates

ND group consumed 55% of the caloric intake from carbohydrates

Outcomes

Primary Outcome Measures

Fat Mass
fat mass measured through body impedence analyser
Lean Body Mass
lean body mass mass measured through body impedence analyser
Maximal muscle strength
muscle strength measured via 1-RM test

Secondary Outcome Measures

blood glucose
glucose as milligram per deciliter
testosterone
Testosterone free as picogram per milliliter
inflammatory cytokines
IL6, IL1β, TNFα measured as nanogram per deciliter
resting metabolism
resting energy expenditure measured as Kcal / day

Full Information

First Posted
November 9, 2020
Last Updated
November 13, 2020
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT04629365
Brief Title
Effects of Ketogenic Diet in Body Builders
Official Title
Effects of Two Months of Ketogenic Diet on Body Composition, Muscle Strength and Blood Parameters in Competitive Natural Body Builders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, Body Weight
Keywords
ketogenic diet, body builders, athletes, body composition, hormones

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor treated anonymus data
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic Diet
Arm Type
Experimental
Arm Description
KD group consumed less than 50g/day of carbohydrates
Arm Title
Normal Diet
Arm Type
Active Comparator
Arm Description
ND group consumed 55% of the caloric intake from carbohydrates
Intervention Type
Other
Intervention Name(s)
Ketogenic Diet
Intervention Description
KD group consumed less than 50g/day of carbohydrates
Intervention Type
Other
Intervention Name(s)
Normal Diet
Intervention Description
ND group consumed 55% of the caloric intake from carbohydrates
Primary Outcome Measure Information:
Title
Fat Mass
Description
fat mass measured through body impedence analyser
Time Frame
8 weeks
Title
Lean Body Mass
Description
lean body mass mass measured through body impedence analyser
Time Frame
8 weeks
Title
Maximal muscle strength
Description
muscle strength measured via 1-RM test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
blood glucose
Description
glucose as milligram per deciliter
Time Frame
8 weeks
Title
testosterone
Description
Testosterone free as picogram per milliliter
Time Frame
8 weeks
Title
inflammatory cytokines
Description
IL6, IL1β, TNFα measured as nanogram per deciliter
Time Frame
8 weeks
Title
resting metabolism
Description
resting energy expenditure measured as Kcal / day
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Paoli, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition and Exercise Lab, DSB, University of Padova
City
Padova
ZIP/Postal Code
35131
Country
Italy

12. IPD Sharing Statement

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Effects of Ketogenic Diet in Body Builders

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