Exercise TrainingNCT05849350
Protein Supplementation in Pilates Training
A study testing Whey protein and Maltodextrin in people with Exercise Training and Dietary Supplements, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Pilates training, a type of mind and body exercise that focuses on muscle strength and flexibility, has become increasingly popular in recent years. Research has shown that Pilates could be an effective exercise form to improve body composition, particularly in obese individuals, while beneficial effects on… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Dietary Supplements
- What is being tested?
- Whey protein and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jan 2023to 31 May 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eumenorrheic (regular menstrual cycle) women
- Regular Pilates training (at least 2 times a week, 50 min each session, for the past 4 months), as assessed by gym records or questionnaires
- Mixed isoenergetic diet for the past 4 months
Who cannot join
- Any musculoskeletal injuries that could interfere with training
- Chronic disease
- Milk allergy
- Pregnancy, lactation, or planning a pregnancy within the duration of the study
- Regular use of prescription medicine or supplements that might affect muscle function or recovery over the past month
- Intermittent or religious fasting
- Any vegetarian, ketogenic or protein diet
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Evaluation of Human Biological Performance
Thessaloniki, 57001
About this study
Official title: Effects of Pilates Training and Protein Supplementation on Body Composition, Performance, and Biochemical Indices
Pilates training, a type of mind and body exercise that focuses on muscle strength and flexibility, has become increasingly popular in recent years. Research has shown that Pilates could be an effective exercise form to improve body composition, particularly in obese individuals, while beneficial effects on flexibility, muscular strength, and muscular endurance have also been observed in young and older adults. It is well documented that protein supplementation can augment the effects of resistance training on body composition and performance. While there is an abundance of studies investigating the effect of protein supplements on adaptations to resistance exercise, there is a knowledge gap regarding their effectiveness in Pilates training.
The aim of this research is to investigate the effects of protein supplementation, compared to placebo (maltodextrin) on body composition, performance, and biochemical indices in healthy young and middle-aged, eumenorrheic (regular menstrual cycle) women who perform Pilates. Participants will be randomly assigned to receive either 0.6 g of whey protein or maltodextrin per kg body weight per day for 10 weeks. Participants will be asked to avoid modifying their dietary habits for the duration of the study to limit the effect of diet on the measured parameters. To check for this, participants will record their diet for 3 days (2 weekdays and one weekend day) on the first, middle, and last weeks of the intervention. Dietary records will then be analyzed. Pilates classes will be performed at least two times per week, while specialized Pilates equipment (Reformer or Cadillac) will be used according to the Pilates principles. The duration of each workout will be set at around 50 min.
Participants will undergo measurements of body composition, core muscle endurance, and joint flexibility at the beginning and end of the study. In addition, hematologic parameters, clinical chemistry parameters, hormones, and plasma amino acids will be measured. All these outcome measures will be compared between the whey protein and maltodextrin groups to determine the effectiveness of protein supplementation in Pilates training.
- Conditions
- Exercise Training, Dietary Supplements
- Being tested
- Whey protein, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Intake of whey protein
MaltodextrinDietary supplement
Intake of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Protein | Experimental | Participants will receive a whey protein supplement. Receives: Dietary Supplement: Whey protein |
| Maltodextrin | Placebo comparator | Participants will receive an isocaloric maltodextrin supplement. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean mass and fat mass pre-supplementation
Lean mass and fat mass of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry. Whole body lean, dry lean and fat mass will also be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week before the beginning of supplementation.
Lean mass and fat mass post-supplementation
Lean mass and fat mass of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry. Whole body lean, dry lean and fat mass will also be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week after the end of supplementation.
Bone mineral density pre-supplementation
Bone mineral density of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Measured: Within one week before the beginning of supplementation.
Bone mineral density post-supplementation
Bone mineral density of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Measured: Within one week after the end of supplementation.
Bone mineral content pre-supplementation
Bone mineral content of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Measured: Within one week before the beginning of supplementation.
Bone mineral content post-supplementation
Bone mineral content of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Measured: Within one week after the end of supplementation.
Bone area pre-supplementation
Bone area of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Measured: Within one week before the beginning of supplementation.
Bone area post-supplementation
Bone area of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Measured: Within one week after the end of supplementation.
Body fat % and lean % pre-supplementation
Body fat as a % of total body weight will be assessed by dual X-ray absorptiometry and multifrequency bioelectrical impedance analysis. Lean as a % of total body weight will be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week before the beginning of supplementation.
Body fat % and lean % post-supplementation
Body fat as a % of total body weight will be assessed by dual X-ray absorptiometry and multifrequency bioelectrical impedance analysis. Lean as a % of total body weight will be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week after the end of supplementation.
Body weight pre-supplementation
Body weight will be measured with an electronic scale to the nearest 0.1 kg
Measured: Within one week before the beginning of supplementation.
Body weight post-supplementation
Body weight will be measured with an electronic scale to the nearest 0.1 kg
Measured: Within one week after the end of supplementation.
Waist and hip circumferences pre-supplementation
Waist and hip circumferences will be measured with a non-extendable tape
Measured: Within one week before the beginning of supplementation.
Waist and hip circumferences post-supplementation
Waist and hip circumferences will be measured with a non-extendable tape
Measured: Within one week after the end of supplementation.
Joint flexibility pre-supplementation
Joint flexibility will be assessed through the sit and reach test.
Measured: Within one week before the beginning of supplementation.
Joint flexibility post-supplementation
Joint flexibility will be assessed through the sit and reach test.
Measured: Within one week after the end of supplementation.
Core muscle endurance pre-supplementation
Core muscle endurance (trunk flexor, trunk lateral right, trunk lateral left, and trunk extensors) will be assessed through the McGill's torso muscular endurance test battery.
Measured: Within one week before the beginning of supplementation.
Core muscle endurance post-supplementation
Core muscle endurance (trunk flexor, trunk lateral right, trunk lateral left, and trunk extensors) will be assessed through the McGill's torso muscular endurance test battery.
Measured: Within one week after the end of supplementation.
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols pre-supplementation
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Measured: Within one week before the beginning of supplementation.
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols post-supplementation
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Measured: Within one week after the end of supplementation.
Plasma amino acid profile pre-supplementation
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography-mass spectrometry.
Measured: Within one week before the beginning of supplementation.
Plasma amino acid profile post-supplementation
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography-mass spectrometry.
Measured: Within one week after the end of supplementation.
Secondary outcomes (18)
Full blood count pre-supplementation
Full blood count will be performed by flow cytometry
Measured: Within one week before the beginning of supplementation.
Full blood count post-supplementation
Full blood count will be performed by flow cytometry
Measured: Within one week after the end of supplementation.
Plasma enzymes pre-supplementation
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer
Measured: Within one week before the beginning of supplementation.
Plasma enzymes post-supplementation
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer
Measured: Within one week after the end of supplementation.
Cortisol pre-supplementation
Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within one week before the beginning of supplementation.
Cortisol post-supplementation
Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within one week after the end of supplementation.
Progesterone and testosterone pre-supplementation
Plasma progesterone and testosterone (both in ng/dL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within one week before the beginning of supplementation.
Progesterone and testosterone post-supplementation
Plasma progesterone and testosterone (both in ng/dL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within one week after the end of supplementation.
Estradiol pre-supplementation
Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within one week before the beginning of supplementation.
Estradiol post-supplementation
Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within one week after the end of supplementation.
Plasma urea and creatinine pre-supplementation
Plasma urea and creatinine (both in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Measured: Within one week before the beginning of supplementation.
Plasma urea and creatinine post-supplementation
Plasma urea and creatinine (both in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Measured: Within one week after the end of supplementation.
Total body water %, intracellular water %, and extracellular water % pre-supplementation
Total body water, intracellular water, and extracellular water (all as % of total body weight) will be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week before the beginning of supplementation.
Total body water %, intracellular water %, and extracellular water % post-supplementation
Total body water, intracellular water, and extracellular water (all as % of total body weight) will be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week after the end of supplementation.
Total body water, intracellular water, and extracellular water pre-supplementation
Total body water, intracellular water, and extracellular water (all in Lt) will be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week before the beginning of supplementation.
Total body water, intracellular water, and extracellular water post-supplementation
Total body water, intracellular water, and extracellular water (all in Lt) will be assessed by multifrequency bioelectrical impedance analysis.
Measured: Within one week after the end of supplementation.
Body mass index (BMI) pre-supplementation
BMI will be calculated by divinding weight by height squared.
Measured: Within one week before the beginning of supplementation
Body mass index (BMI) post-supplementation
BMI will be calculated by divinding weight by height squared.
Measured: Within one week after the end of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start20 Jan 2023
- Primary completion9 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849350
- Sponsor's protocol ID
- PilatesProtein1
- Status last verified
- Mar 2024
- First submitted
- 28 Apr 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Training and Protein Supplementation on Body Composition, Performance, and Biochemical Indices
- ClinicalTrials.gov ID
- NCT05849350
- Acronym / sponsor ID
- PilatesProtein1
- Conditions
- Exercise Training, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 8 May 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.
Pilates training, a type of mind and body exercise that focuses on muscle strength and flexibility, has become increasingly popular in recent years. Research has shown that Pilates could be an effective exercise form to improve body composition, particularly in obese individuals, while beneficial effects on flexibility, muscular strength, and muscular endurance have also been observed in young and older adults. It is well documented that protein supplementation can augment the effects of resistance training on body composition and performance. While there is an abundance of studies investigating the effect of protein supplements on adaptations to resistance exercise, there is a knowledge gap regarding their effectiveness in Pilates training.
The aim of this research is to investigate the effects of protein supplementation, compared to placebo (maltodextrin) on body composition, performance, and biochemical indices in healthy young and middle-aged, eumenorrheic (regular menstrual cycle) women who perform Pilates. Participants will be randomly assigned to receive either 0.6 g of whey protein or maltodextrin per kg body weight per day for 10 weeks. Participants will be asked to avoid modifying their dietary habits for the duration of the study to limit the effect of diet on the measured parameters. To check for this, participants will record their diet for 3 days (2 weekdays and one weekend day) on the first, middle, and last weeks of the intervention. Dietary records will then be analyzed. Pilates classes will be performed at least two times per week, while specialized Pilates equipment (Reformer or Cadillac) will be used according to the Pilates principles. The duration of each workout will be set at around 50 min.
Participants will undergo measurements of body composition, core muscle endurance, and joint flexibility at the beginning and end of the study. In addition, hematologic parameters, clinical chemistry parameters, hormones, and plasma amino acids will be measured. All these outcome measures will be compared between the whey protein and maltodextrin groups to determine the effectiveness of protein supplementation in Pilates training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein | Experimental | Dietary Supplement: Whey proteinParticipants will receive a whey protein supplement. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinParticipants will receive an isocaloric maltodextrin supplement. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eumenorrheic (regular menstrual cycle) women
- Regular Pilates training (at least 2 times a week, 50 min each session, for the past 4 months), as assessed by gym records or questionnaires
- Mixed isoenergetic diet for the past 4 months
Key exclusion criteria (7 listed)
- Any musculoskeletal injuries that could interfere with training
- Chronic disease
- Milk allergy
- Pregnancy, lactation, or planning a pregnancy within the duration of the study
- Regular use of prescription medicine or supplements that might affect muscle function or recovery over the past month
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 |
|---|---|---|
| Whey proteinIntake of whey protein | Dietary supplement | Protein |
| MaltodextrinIntake of maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Lean mass and fat mass pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Lean mass and fat mass of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry. Whole body lean, dry lean and fat mass will also be assessed by multifrequency bioelectrical impedance analysis.
Lean mass and fat mass post-supplementation
Time frame: Within one week after the end of supplementation.
Lean mass and fat mass of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry. Whole body lean, dry lean and fat mass will also be assessed by multifrequency bioelectrical impedance analysis.
Bone mineral density pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Bone mineral density of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Bone mineral density post-supplementation
Time frame: Within one week after the end of supplementation.
Bone mineral density of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Bone mineral content pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Bone mineral content of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Bone mineral content post-supplementation
Time frame: Within one week after the end of supplementation.
Bone mineral content of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Bone area pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Bone area of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Bone area post-supplementation
Time frame: Within one week after the end of supplementation.
Bone area of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Body fat % and lean % pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Body fat as a % of total body weight will be assessed by dual X-ray absorptiometry and multifrequency bioelectrical impedance analysis. Lean as a % of total body weight will be assessed by multifrequency bioelectrical impedance analysis.
Body fat % and lean % post-supplementation
Time frame: Within one week after the end of supplementation.
Body fat as a % of total body weight will be assessed by dual X-ray absorptiometry and multifrequency bioelectrical impedance analysis. Lean as a % of total body weight will be assessed by multifrequency bioelectrical impedance analysis.
Body weight pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Body weight will be measured with an electronic scale to the nearest 0.1 kg
Body weight post-supplementation
Time frame: Within one week after the end of supplementation.
Body weight will be measured with an electronic scale to the nearest 0.1 kg
Waist and hip circumferences pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Waist and hip circumferences will be measured with a non-extendable tape
Waist and hip circumferences post-supplementation
Time frame: Within one week after the end of supplementation.
Waist and hip circumferences will be measured with a non-extendable tape
Joint flexibility pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Joint flexibility will be assessed through the sit and reach test.
Joint flexibility post-supplementation
Time frame: Within one week after the end of supplementation.
Joint flexibility will be assessed through the sit and reach test.
Core muscle endurance pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Core muscle endurance (trunk flexor, trunk lateral right, trunk lateral left, and trunk extensors) will be assessed through the McGill's torso muscular endurance test battery.
Core muscle endurance post-supplementation
Time frame: Within one week after the end of supplementation.
Core muscle endurance (trunk flexor, trunk lateral right, trunk lateral left, and trunk extensors) will be assessed through the McGill's torso muscular endurance test battery.
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols post-supplementation
Time frame: Within one week after the end of supplementation.
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Plasma amino acid profile pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography-mass spectrometry.
Plasma amino acid profile post-supplementation
Time frame: Within one week after the end of supplementation.
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography-mass spectrometry.
18 secondary outcomes
Full blood count pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Full blood count post-supplementation
Time frame: Within one week after the end of supplementation.
Plasma enzymes pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Plasma enzymes post-supplementation
Time frame: Within one week after the end of supplementation.
Cortisol pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Cortisol post-supplementation
Time frame: Within one week after the end of supplementation.
Progesterone and testosterone pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Progesterone and testosterone post-supplementation
Time frame: Within one week after the end of supplementation.
Estradiol pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Estradiol post-supplementation
Time frame: Within one week after the end of supplementation.
Plasma urea and creatinine pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Plasma urea and creatinine post-supplementation
Time frame: Within one week after the end of supplementation.
Total body water %, intracellular water %, and extracellular water % pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Total body water %, intracellular water %, and extracellular water % post-supplementation
Time frame: Within one week after the end of supplementation.
Total body water, intracellular water, and extracellular water pre-supplementation
Time frame: Within one week before the beginning of supplementation.
Total body water, intracellular water, and extracellular water post-supplementation
Time frame: Within one week after the end of supplementation.
Body mass index (BMI) pre-supplementation
Time frame: Within one week before the beginning of supplementation
Body mass index (BMI) post-supplementation
Time frame: Within one week after the end of supplementation.
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 22 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and Maltodextrin in people with Exercise Training and Dietary Supplements, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 7 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 22 Mar 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Lean mass and fat mass pre-supplementation (time frame: Within one week before the beginning of supplementation.). The study lists 22 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 22 Mar 2024.