Diet, HealthyNCT04629365
Effects of Ketogenic Diet in Body Builders
A study testing Ketogenic Diet and Normal Diet in people with Diet, Healthy and Body Weight, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Body Weight
- What is being tested?
- Ketogenic Diet and Normal Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 5 years of training experiences
- competing in recognized body building category
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet, Healthy, Body Weight
- Being tested
- Ketogenic Diet, Normal Diet
- Keywords
- ketogenic diet, body builders, athletes, body composition, hormones
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
KD group consumed less than 50g/day of carbohydrates
Normal DietOther
ND group consumed 55% of the caloric intake from carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | KD group consumed less than 50g/day of carbohydrates Receives: Other: Ketogenic Diet |
| Normal Diet | Active comparator | ND group consumed 55% of the caloric intake from carbohydrates Receives: Other: Normal Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Mass
fat mass measured through body impedence analyser
Measured: 8 weeks
Lean Body Mass
lean body mass mass measured through body impedence analyser
Measured: 8 weeks
Maximal muscle strength
muscle strength measured via 1-RM test
Measured: 8 weeks
Secondary outcomes (4)
blood glucose
glucose as milligram per deciliter
Measured: 8 weeks
testosterone
Testosterone free as picogram per milliliter
Measured: 8 weeks
inflammatory cytokines
IL6, IL1β, TNFα measured as nanogram per deciliter
Measured: 8 weeks
resting metabolism
resting energy expenditure measured as Kcal / day
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jan 2020
- Primary completion31 Aug 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629365
- Sponsor's protocol ID
- BBKeto
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Months of Ketogenic Diet on Body Composition, Muscle Strength and Blood Parameters in Competitive Natural Body Builders
- ClinicalTrials.gov ID
- NCT04629365
- Acronym / sponsor ID
- BBKeto
- Conditions
- Diet, Healthy, Body Weight
- Keywords
- ketogenic diet, body builders, athletes, body composition, hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Ketogenic DietKD group consumed less than 50g/day of carbohydrates |
| Normal Diet | Active comparator | Other: Normal DietND group consumed 55% of the caloric intake from carbohydrates |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- at least 5 years of training experiences
- competing in recognized body building category
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic DietKD group consumed less than 50g/day of carbohydrates | Other | Ketogenic Diet |
| Normal DietND group consumed 55% of the caloric intake from carbohydrates | Other | Normal Diet |
Primary outcome
Fat Mass
Time frame: 8 weeks
fat mass measured through body impedence analyser
Lean Body Mass
Time frame: 8 weeks
lean body mass mass measured through body impedence analyser
Maximal muscle strength
Time frame: 8 weeks
muscle strength measured via 1-RM test
4 secondary outcomes
blood glucose
Time frame: 8 weeks
testosterone
Time frame: 8 weeks
inflammatory cytokines
Time frame: 8 weeks
resting metabolism
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Paoli, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet and Normal Diet in people with Diet, Healthy and Body Weight, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Mass (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.