- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629365
Effects of Ketogenic Diet in Body Builders
November 13, 2020 updated by: Antonio Paoli, University of Padova
Effects of Two Months of Ketogenic Diet on Body Composition, Muscle Strength and Blood Parameters in Competitive Natural Body Builders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Padova, Italy, 35131
- Nutrition and Exercise Lab, DSB, University of Padova
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ketogenic Diet
KD group consumed less than 50g/day of carbohydrates
|
KD group consumed less than 50g/day of carbohydrates
|
|
ACTIVE_COMPARATOR: Normal Diet
ND group consumed 55% of the caloric intake from carbohydrates
|
ND group consumed 55% of the caloric intake from carbohydrates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat Mass
Time Frame: 8 weeks
|
fat mass measured through body impedence analyser
|
8 weeks
|
|
Lean Body Mass
Time Frame: 8 weeks
|
lean body mass mass measured through body impedence analyser
|
8 weeks
|
|
Maximal muscle strength
Time Frame: 8 weeks
|
muscle strength measured via 1-RM test
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood glucose
Time Frame: 8 weeks
|
glucose as milligram per deciliter
|
8 weeks
|
|
testosterone
Time Frame: 8 weeks
|
Testosterone free as picogram per milliliter
|
8 weeks
|
|
inflammatory cytokines
Time Frame: 8 weeks
|
IL6, IL1β, TNFα measured as nanogram per deciliter
|
8 weeks
|
|
resting metabolism
Time Frame: 8 weeks
|
resting energy expenditure measured as Kcal / day
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2020
Primary Completion (ACTUAL)
August 31, 2020
Study Completion (ACTUAL)
October 31, 2020
Study Registration Dates
First Submitted
November 9, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (ACTUAL)
November 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2020
Last Update Submitted That Met QC Criteria
November 13, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBKeto
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.