Healthy NutritionNCT05897567
Effect of Ketogenic Diet on Muscle Hypertrophy
A study testing resistance training, ketogenic diet and western diet in people with Healthy Nutrition, run by University of Padova at 1 site in Italy.
Trial summary
The purpose of this study is to investigate the effects of 4 weeks of carbohydrate deprivation (through a ketogenic diet) on hypertrophy signalling after a single bout of exercise in healthy trained male subjects, and the impact on body composition, muscle strength, and blood parameters. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- resistance training, ketogenic diet and western diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2023to 31 Dec 2025
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 2 years of resistance-training experience
- Body mass index: more than 18 kg/m2 and less than 30 kg/m2
Who cannot join
- metabolic diseases or noncommunicable diseases (cardiovascular, liver, respiratory, cancer, etc)
- experience with the ketogenic diet (last six months)
- acute inflammatory status
- treatment with steroids in the past 3 months
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Nutex LAB
Padua, 35131
Antonio Paoli, MD, +390498275318, antonio.paoli@unipd.it
About this study
Official title: Effects of Ketogenic Diet on Muscle Hypertrophic Response to Resistance Exercise
The purpose of this study is to investigate the effects of 4 weeks of carbohydrate deprivation (through a ketogenic diet) on hypertrophy signalling after a single bout of exercise in healthy trained male subjects, and the impact on body composition, muscle strength, and blood parameters.
- Conditions
- Healthy Nutrition
- Being tested
- resistance training, ketogenic diet, western diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingOther
All participants perform a four-day resistance training aimed to stimulate a hypertrophic response.
ketogenic dietOther
Subjects allocated to the ketogenic diet arm (KD group) consume less than 50 g of carbohydrates per day.
western dietOther
Subjects allocated to the western diet arm (WD group) consume a standard diet based on 55% of their daily calories from carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet | Experimental | Participants will perform a single exercise bout after 4 weeks of resistance training combined with a ketogenic diet (KD group). Receives: Other: resistance training; Other: ketogenic diet |
| western diet | Active comparator | Participants will perform a single exercise bout after 4 weeks of resistance training combined with a western diet (WD group). Receives: Other: resistance training; Other: western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
mammalian target of rapamycin (mTOR) signalling
Measurement of the change in muscle protein anabolic signalling pathway in response to a single bout of resistance exercise by western blot analysis.
Measured: Change from baseline to 4 weeks
Secondary outcomes (1)
Skeletal muscle mass
Measurement of the change in kilograms of muscle mass via Dexa
Measured: Change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start20 Jun 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897567
- Sponsor's protocol ID
- KETO-EX
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketogenic Diet on Muscle Hypertrophic Response to Resistance Exercise
- ClinicalTrials.gov ID
- NCT05897567
- Acronym / sponsor ID
- KETO-EX
- Conditions
- Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jun 2023 (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 purpose of this study is to investigate the effects of 4 weeks of carbohydrate deprivation (through a ketogenic diet) on hypertrophy signalling after a single bout of exercise in healthy trained male subjects, and the impact on body composition, muscle strength, and blood parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet | Experimental | Other: resistance training, Other: ketogenic dietParticipants will perform a single exercise bout after 4 weeks of resistance training combined with a ketogenic diet (KD group). |
| western diet | Active comparator | Other: resistance training, Other: western dietParticipants will perform a single exercise bout after 4 weeks of resistance training combined with a western diet (WD group). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- at least 2 years of resistance-training experience
- Body mass index: more than 18 kg/m2 and less than 30 kg/m2
Key exclusion criteria (4 listed)
- metabolic diseases or noncommunicable diseases (cardiovascular, liver, respiratory, cancer, etc)
- experience with the ketogenic diet (last six months)
- acute inflammatory status
- treatment with steroids in the past 3 months
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 |
|---|---|---|
| resistance trainingAll participants perform a four-day resistance training aimed to stimulate a hypertrophic response. | Other | ketogenic diet, western diet |
| ketogenic dietSubjects allocated to the ketogenic diet arm (KD group) consume less than 50 g of carbohydrates per day. | Other | ketogenic diet |
| western dietSubjects allocated to the western diet arm (WD group) consume a standard diet based on 55% of their daily calories from carbohydrates. | Other | western diet |
Primary outcome
mammalian target of rapamycin (mTOR) signalling
Time frame: Change from baseline to 4 weeks
Measurement of the change in muscle protein anabolic signalling pathway in response to a single bout of resistance exercise by western blot analysis.
1 secondary outcome
Skeletal muscle mass
Time frame: Change from baseline to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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 resistance training, ketogenic diet and western diet in people with Healthy Nutrition, 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Cerullo (+00393200218377, giuseppe.cerullo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mammalian target of rapamycin (mTOR) signalling (time frame: Change from baseline to 4 weeks). 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 10 May 2024.