Healthy Men Doing Resistance TrainingNCT07735988
Effects of Soy Protein and Creatine Supplementation on Certain Parameters in Men Performing Resistance Exercise
A study testing soy protein and Creatine Monohydrate in people with Healthy Men Doing Resistance Training, run by Yakup Enes Çam at 1 site in Turkey (Türkiye).
Trial summary
The study will consist of a total of four visits. On the day of the first visit, participants who volunteer to take part in the study will be informed about the research, informed consent forms will be completed, and forms for recording a three-day dietary intake record will be provided. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men Doing Resistance Training
- What is being tested?
- soy protein and Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 2 Mar 2026
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 18-35 years old,
- Having regularly performed resistance training for at least one year,
- Not having any metabolic disease,
- Not taking any regular medication,
- Not using any nutritional supplements in the last three months prior to the study.
Who cannot join
- Being between 18 and 35 years old,
- Having done resistance training for less than a year,
- Smoking and drinking alcohol,
- Taking regular medication,
- Having an allergy to soy protein,
- Having a psychiatric illness,
- Being female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Soy Protein and Creatine Supplementation on Body Composition, Acute Muscle Injury, and Biochemical Parameters in Trained Men Performing Resistance Exercise
The study will consist of a total of four visits. On the day of the first visit, participants who volunteer to take part in the study will be informed about the research, informed consent forms will be completed, and forms for recording a three-day dietary intake record will be provided. The second visit will be conducted three days after the first visit; during this visit, the dietary intake records distributed in the first visit will be collected, and diet programs along with supplements will be distributed to the participants. The third visit will take place 53 days after the second visit. During the third visit, a three-day dietary intake record form will be distributed to assess the participants' compliance with the diet. The final visit will be conducted three days after the third visit. In the last session, the participants' three-day dietary intake records, BIA, skinfold thickness, body circumference measurements, and handgrip strength measurements will be obtained, and the study will be concluded.
Read the detailed description
This study was designed as a randomized controlled trial. The study will be conducted with 54 male participants aged 18-35 years (CrM: 18, Soy: 18, Placebo: 18) who regularly attend gyms located in the Central district of Bitlis province and apply to the laboratory of Bitlis State Hospital. Data collection is planned between December 2025 and February 2026. Inclusion criteria for the study were determined as being between 18 and 35 years of age, engaging in regular resistance training for at least one year, having no metabolic diseases, not using regular medication, and not having used any dietary supplements in the last three months prior to the study. Exclusion criteria were defined as being under 18 or over 35 years of age, engaging in resistance exercise for less than one year, using tobacco and alcohol, using regular medication, having an allergy to soy protein, having a psychiatric disorder, and being female.
Voluntary individuals evaluated according to the inclusion criteria and deemed suitable for participation will be randomized using the 'Block Randomization' method. One-third of the individuals selected through the randomization method will be given creatine monohydrate supplementation, one-third soy protein supplementation, and one-third placebo. While all products to be used in our study are provided by a company with GMP (Good Manufacturing Practices) certification, products commonly consumed by athletes will be used, as stated in the literature summary. Creatine and soy protein are products that are widely used as dietary supplements in the market and are accepted as safe. Both products will be used within recommended dose limits. No invasive procedures will be performed on the participants in our study (no blood sampling will be conducted); participants who are routinely checked by a specialist physician will be included in the study.
A Personal Information Form, prepared by the researchers through a literature review, will be administered to the participating individuals using the face-to-face interview technique. The Personal Information Form questions consist of 15 open-ended and multiple-choice questions aimed at determining the individuals' general information, dietary habits, dietary supplement use, and nutrition and hydration status during training.
To evaluate the nutritional status of the participants, a consecutive three-day (two weekdays and one weekend day) dietary intake record will be taken at the beginning and end of the study. A three-day Food Record Form will be given to the participants during the first and fourth visits, and how to complete it will be explained to the individuals. After the records are collected, the amounts and contents of the consumed foods will be detailed and questioned by the participants and the researcher. In the evaluation of foods consumed at home, the book 'Food and Nutrition Photo Catalogue: Measures and Amounts' will be utilized. The portion contents of meals consumed by individuals outside the home will be calculated using the book 'Standard Food Recipes for Institutions Serving Mass Catering'. Dietary intake records will be analyzed using the BeBIS Nutrition Information System (Germany) 7.2 software, and the daily average energy and macro/micronutrient amounts consumed by the individuals will be determined.
Biochemical parameters to be used in the study will be obtained from the individuals' files within the scope of routine analyses performed during routine applications to Bitlis State Hospital. Hemogram values, creatine kinase, fasting blood glucose, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, AST, ALT, ALP, iron, ferritin, and testosterone values of all individuals participating in the study will be used.
The study will consist of a total of four visits. On the day of the first visit, participants who volunteer to take part in the study will be informed about the research, informed consent forms will be completed, and forms for recording a three-day dietary intake record will be provided. The second visit will be conducted three days after the first visit; during this visit, the dietary intake records distributed in the first visit will be collected, and diet programs along with supplements will be distributed to the participants. The third visit will take place 53 days after the second visit. During the third visit, a three-day dietary intake record form will be distributed to assess the participants' compliance with the diet. The final visit will be conducted three days after the third visit. In the last session, the participants' three-day dietary intake records, BIA, skinfold thickness, body circumference measurements, and handgrip strength measurements will be obtained, and the study will be concluded.
Within the scope of the first and fourth visit monitoring, the body weight and body composition measurements of the individuals will be performed with the help of a Bioelectrical Impedance Analysis (BIA) device (Tanita BC 601, Japan). Measurements will be taken following a fast of at least 12 hours, after asking participants not to engage in heavy activity the previous day and not to consume drinks with diuretic properties such as tea and coffee. Metallic jewelry will be removed during the measurement. As a result of the measurement, the individuals' body weight (kg), body fat percentage, body fat mass (kg), fat-free mass (kg), and body muscle mass (kg) values will be determined. Skinfold thickness measurements will be taken from the biceps, triceps, subscapular, and suprailiac regions using a Holtain brand caliper. Participants' waist circumference and hip circumference measurements will be taken using a tape measure. Participants' handgrip strength measurements will be taken from both hands with three repetitions using a Herklotzn 120 kg (Germany) hand dynamometer. Participants will be asked to squeeze the dynamometer with all their strength, and the highest value obtained will be recorded. At the end of the study, initial measurement values and final measurement values will be compared between the groups.
The Personal Information Form will be completed for the participants, and the diets and supplements to be applied during the study will be given to the participants by the researchers. During the second visit, the REE (Resting Energy Expenditure) values of the individuals will be calculated by the researchers using the Mifflin-St. Joer calculation formula. The daily basic activities of the participants will be questioned by the researchers, and the physical activity coefficient will be calculated. As a result of the calculations made, the total energy requirement of each individual will be calculated, and the diets of the individuals will be planned according to the Dietary Guidelines for Turkey (TÜBER).
Among the nutritional supplements to be used in the research, 5 g/day of creatine monohydrate, which is recommended for the loading period and used in many studies in the literature, will be provided by dissolving it in 500 mL of water prior to exercise.
In a meta-analysis study conducted with soy protein, it was observed that the effective dose ranges used in the study were 10-53.3 g/day. However, in most studies conducted, the supplement dose was seen to be 22 g/day, and in our study, 22 g/day of soy protein supplement will be provided by dissolving it in 500 mL of water prior to exercise. For placebo supplementation, a powdered placebo content produced using maltodextrin by a company with GMP (Good Manufacturing Practices) certification will be used. Placebo supplementation will also be consumed by dissolving 25 g/day in 500 mL of water prior to exercise.
Periodic, free-weight resistance training will be applied to the individuals in the study for 8 weeks. Training will start on the first day of supplementation, and training programs containing all body muscles (4 days/week) will be applied. Each exercise session will end with a 10-minute treadmill warmup, 40 minutes of resistance exercise, and a 5-minute cooldown phase. The first day of training will consist of a total of 7 different exercises targeting chest and triceps muscles (Triceps: Triceps push down, lying dumbbell triceps extension, overhead triceps extension; Chest: Bench press, incline dumbbell fly, pec deck fly, chest dip). Each exercise will consist of 4 sets and 8-12 repetitions. The second day of training will consist of a total of 7 exercises involving back and biceps muscles (Back: Lat pulldown, chin up, pull up, deadlift; Biceps: Barbell biceps curl, seated dumbbell biceps curl, hammer curl). Each exercise will consist of 4 sets and 8-12 repetitions. The third day of training will consist of 5 exercises targeting shoulder muscles (overhead press, front raise, rear delt fly, full can). Each exercise will consist of a total of 3 sets and 10-15 repetitions. The fourth day of training will consist of a total of 7 different exercises targeting leg and abdominal muscles (Leg: Leg curl, squat, leg press, hamstring curl; Abdomen: Abdominal crunch, legs up crunch, side crunch). Each exercise will consist of a total of 4 sets and 8-15 repetitions. Individuals will be informed that they should rest for approximately one minute after each set.
- Conditions
- Healthy Men Doing Resistance Training
- Being tested
- soy protein, Creatine Monohydrate
- Keywords
- Creatine, Soy protein, Resistance Training, Body Composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy proteinDietary supplement
The first study to compare creatine supplementation.
Creatine MonohydrateDietary supplement
This is the first study to compare soy protein to a placebo.
| Study group | Role | What they receive |
|---|---|---|
| CrM | Placebo comparator | Not using any nutritional supplements in the three months prior to the study, and not having a sensitivity to creatine. Receives: Dietary Supplement: Creatine Monohydrate |
| Soy | Placebo comparator | not using any nutritional supplements in the three months prior to the study not having an allergy to soy protein Receives: Dietary Supplement: soy protein |
| Placebo | No intervention | Healthy men who do resistance training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Composition Parameters (Skeletal Muscle Mass and Body Fat Percentage) Assessed by Bioelectrical Impedance Analysis (BIA)
Evaluated using a multi-frequency bioelectrical impedance analyzer to measure changes in skeletal muscle mass (kg) and body fat percentage (%) from baseline to the end of the 8-week intervention period.
Measured: Baseline and 8 weeks
Change in Serum Total Testosterone Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA)
Evaluated via fasting blood serum analysis to determine changes in total testosterone concentrations from baseline to the end of the 8-week intervention period.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Change in Serum Biomarkers of Muscle Damage (Creatine Kinase and Lactate Dehydrogenase) Assessed by Autoanalyzer
Fasting blood samples were analyzed to determine changes in serum creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations from baseline to week 8.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start5 Jan 2026
- Primary completion2 Feb 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy Men Doing Resistance 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
- Model description
- The study was conducted with 54 males aged 18-35 years (CrM: 18, Soy: 18, Placebo: 18) who regularly attended gyms in the central district of Bitlis province and applied to the Bitlis State Hospital laboratory.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yakup Enes Çam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yakup Enes Çam, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735988
- Sponsor's protocol ID
- 2025/1327
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All
Publications
Nieman DC. Current and Novel Reviews in Sports Nutrition. Nutrients. 2021 Jul 26;13(8):2549. doi: 10.3390/nu13082549.
PubMed 34444710Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
PubMed 24605197Churchward-Venne TA, Pinckaers PJM, Smeets JSJ, Peeters WM, Zorenc AH, Schierbeek H, Rollo I, Verdijk LB, van Loon LJC. Myofibrillar and Mitochondrial Protein Synthesis Rates Do Not Differ in Young Men Following the Ingestion of Carbohydrate with Milk Protein, Whey, or Micellar Casein after Concurrent Resistance- and Endurance-Type Exercise. J Nutr. 2019 Feb 1;149(2):198-209. doi: 10.1093/jn/nxy244.
PubMed 30698725Burke LM, Castell LM, Casa DJ, Close GL, Costa RJS, Desbrow B, Halson SL, Lis DM, Melin AK, Peeling P, Saunders PU, Slater GJ, Sygo J, Witard OC, Bermon S, Stellingwerff T. International Association of Athletics Federations Consensus Statement 2019: Nutrition for Athletics. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):73-84. doi: 10.1123/ijsnem.2019-0065. Epub 2019 Apr 5.
PubMed 30952204Berrazaga I, Micard V, Gueugneau M, Walrand S. The Role of the Anabolic Properties of Plant- versus Animal-Based Protein Sources in Supporting Muscle Mass Maintenance: A Critical Review. Nutrients. 2019 Aug 7;11(8):1825. doi: 10.3390/nu11081825.
PubMed 31394788Anthony JC, Anthony TG, Layman DK. Leucine supplementation enhances skeletal muscle recovery in rats following exercise. J Nutr. 1999 Jun;129(6):1102-6. doi: 10.1093/jn/129.6.1102.
PubMed 10356072Berg A, Schaffner D, Pohlmann Y, Baumstark MW, Deibert P, Konig D, Gollhofer A. A soy-based supplement alters energy metabolism but not the exercise-induced stress response. Exerc Immunol Rev. 2012;18:128-41.
PubMed 22876725Bassaganya-Riera J, Berry EM, Blaak EE, Burlingame B, le Coutre J, van Eden W, El-Sohemy A, German JB, Knorr D, Lacroix C, Muscaritoli M, Nieman DC, Rychlik M, Scholey A, Serafini M. Goals in Nutrition Science 2020-2025. Front Nutr. 2021 Feb 9;7:606378. doi: 10.3389/fnut.2020.606378. eCollection 2020.
PubMed 33665201
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soy Protein and Creatine Supplementation on Body Composition, Acute Muscle Injury, and Biochemical Parameters in Trained Men Performing Resistance Exercise
- ClinicalTrials.gov ID
- NCT07735988
- Acronym / sponsor ID
- 2025/1327
- Conditions
- Healthy Men Doing Resistance Training
- Keywords
- Creatine, Soy protein, Resistance Training, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yakup Enes ÇamUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 30 Jul 2026 (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 will consist of a total of four visits. On the day of the first visit, participants who volunteer to take part in the study will be informed about the research, informed consent forms will be completed, and forms for recording a three-day dietary intake record will be provided. The second visit will be conducted three days after the first visit; during this visit, the dietary intake records distributed in the first visit will be collected, and diet programs along with supplements will be distributed to the participants. The third visit will take place 53 days after the second visit. During the third visit, a three-day dietary intake record form will be distributed to assess the participants' compliance with the diet. The final visit will be conducted three days after the third visit. In the last session, the participants' three-day dietary intake records, BIA, skinfold thickness, body circumference measurements, and handgrip strength measurements will be obtained, and the study will be concluded.
Detailed description
This study was designed as a randomized controlled trial. The study will be conducted with 54 male participants aged 18-35 years (CrM: 18, Soy: 18, Placebo: 18) who regularly attend gyms located in the Central district of Bitlis province and apply to the laboratory of Bitlis State Hospital. Data collection is planned between December 2025 and February 2026. Inclusion criteria for the study were determined as being between 18 and 35 years of age, engaging in regular resistance training for at least one year, having no metabolic diseases, not using regular medication, and not having used any dietary supplements in the last three months prior to the study. Exclusion criteria were defined as being under 18 or over 35 years of age, engaging in resistance exercise for less than one year, using tobacco and alcohol, using regular medication, having an allergy to soy protein, having a psychiatric disorder, and being female.
Voluntary individuals evaluated according to the inclusion criteria and deemed suitable for participation will be randomized using the 'Block Randomization' method. One-third of the individuals selected through the randomization method will be given creatine monohydrate supplementation, one-third soy protein supplementation, and one-third placebo. While all products to be used in our study are provided by a company with GMP (Good Manufacturing Practices) certification, products commonly consumed by athletes will be used, as stated in the literature summary. Creatine and soy protein are products that are widely used as dietary supplements in the market and are accepted as safe. Both products will be used within recommended dose limits. No invasive procedures will be performed on the participants in our study (no blood sampling will be conducted); participants who are routinely checked by a specialist physician will be included in the study.
A Personal Information Form, prepared by the researchers through a literature review, will be administered to the participating individuals using the face-to-face interview technique. The Personal Information Form questions consist of 15 open-ended and multiple-choice questions aimed at determining the individuals' general information, dietary habits, dietary supplement use, and nutrition and hydration status during training.
To evaluate the nutritional status of the participants, a consecutive three-day (two weekdays and one weekend day) dietary intake record will be taken at the beginning and end of the study. A three-day Food Record Form will be given to the participants during the first and fourth visits, and how to complete it will be explained to the individuals. After the records are collected, the amounts and contents of the consumed foods will be detailed and questioned by the participants and the researcher. In the evaluation of foods consumed at home, the book 'Food and Nutrition Photo Catalogue: Measures and Amounts' will be utilized. The portion contents of meals consumed by individuals outside the home will be calculated using the book 'Standard Food Recipes for Institutions Serving Mass Catering'. Dietary intake records will be analyzed using the BeBIS Nutrition Information System (Germany) 7.2 software, and the daily average energy and macro/micronutrient amounts consumed by the individuals will be determined.
Biochemical parameters to be used in the study will be obtained from the individuals' files within the scope of routine analyses performed during routine applications to Bitlis State Hospital. Hemogram values, creatine kinase, fasting blood glucose, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, AST, ALT, ALP, iron, ferritin, and testosterone values of all individuals participating in the study will be used.
The study will consist of a total of four visits. On the day of the first visit, participants who volunteer to take part in the study will be informed about the research, informed consent forms will be completed, and forms for recording a three-day dietary intake record will be provided. The second visit will be conducted three days after the first visit; during this visit, the dietary intake records distributed in the first visit will be collected, and diet programs along with supplements will be distributed to the participants. The third visit will take place 53 days after the second visit. During the third visit, a three-day dietary intake record form will be distributed to assess the participants' compliance with the diet. The final visit will be conducted three days after the third visit. In the last session, the participants' three-day dietary intake records, BIA, skinfold thickness, body circumference measurements, and handgrip strength measurements will be obtained, and the study will be concluded.
Within the scope of the first and fourth visit monitoring, the body weight and body composition measurements of the individuals will be performed with the help of a Bioelectrical Impedance Analysis (BIA) device (Tanita BC 601, Japan). Measurements will be taken following a fast of at least 12 hours, after asking participants not to engage in heavy activity the previous day and not to consume drinks with diuretic properties such as tea and coffee. Metallic jewelry will be removed during the measurement. As a result of the measurement, the individuals' body weight (kg), body fat percentage, body fat mass (kg), fat-free mass (kg), and body muscle mass (kg) values will be determined. Skinfold thickness measurements will be taken from the biceps, triceps, subscapular, and suprailiac regions using a Holtain brand caliper. Participants' waist circumference and hip circumference measurements will be taken using a tape measure. Participants' handgrip strength measurements will be taken from both hands with three repetitions using a Herklotzn 120 kg (Germany) hand dynamometer. Participants will be asked to squeeze the dynamometer with all their strength, and the highest value obtained will be recorded. At the end of the study, initial measurement values and final measurement values will be compared between the groups.
The Personal Information Form will be completed for the participants, and the diets and supplements to be applied during the study will be given to the participants by the researchers. During the second visit, the REE (Resting Energy Expenditure) values of the individuals will be calculated by the researchers using the Mifflin-St. Joer calculation formula. The daily basic activities of the participants will be questioned by the researchers, and the physical activity coefficient will be calculated. As a result of the calculations made, the total energy requirement of each individual will be calculated, and the diets of the individuals will be planned according to the Dietary Guidelines for Turkey (TÜBER).
Among the nutritional supplements to be used in the research, 5 g/day of creatine monohydrate, which is recommended for the loading period and used in many studies in the literature, will be provided by dissolving it in 500 mL of water prior to exercise.
In a meta-analysis study conducted with soy protein, it was observed that the effective dose ranges used in the study were 10-53.3 g/day. However, in most studies conducted, the supplement dose was seen to be 22 g/day, and in our study, 22 g/day of soy protein supplement will be provided by dissolving it in 500 mL of water prior to exercise. For placebo supplementation, a powdered placebo content produced using maltodextrin by a company with GMP (Good Manufacturing Practices) certification will be used. Placebo supplementation will also be consumed by dissolving 25 g/day in 500 mL of water prior to exercise.
Periodic, free-weight resistance training will be applied to the individuals in the study for 8 weeks. Training will start on the first day of supplementation, and training programs containing all body muscles (4 days/week) will be applied. Each exercise session will end with a 10-minute treadmill warmup, 40 minutes of resistance exercise, and a 5-minute cooldown phase. The first day of training will consist of a total of 7 different exercises targeting chest and triceps muscles (Triceps: Triceps push down, lying dumbbell triceps extension, overhead triceps extension; Chest: Bench press, incline dumbbell fly, pec deck fly, chest dip). Each exercise will consist of 4 sets and 8-12 repetitions. The second day of training will consist of a total of 7 exercises involving back and biceps muscles (Back: Lat pulldown, chin up, pull up, deadlift; Biceps: Barbell biceps curl, seated dumbbell biceps curl, hammer curl). Each exercise will consist of 4 sets and 8-12 repetitions. The third day of training will consist of 5 exercises targeting shoulder muscles (overhead press, front raise, rear delt fly, full can). Each exercise will consist of a total of 3 sets and 10-15 repetitions. The fourth day of training will consist of a total of 7 different exercises targeting leg and abdominal muscles (Leg: Leg curl, squat, leg press, hamstring curl; Abdomen: Abdominal crunch, legs up crunch, side crunch). Each exercise will consist of a total of 4 sets and 8-15 repetitions. Individuals will be informed that they should rest for approximately one minute after each set.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study was conducted with 54 males aged 18-35 years (CrM: 18, Soy: 18, Placebo: 18) who regularly attended gyms in the central district of Bitlis province and applied to the Bitlis State Hospital laboratory.
| Arm | Type | Receives |
|---|---|---|
| CrM | Placebo comparator | Dietary Supplement: Creatine MonohydrateNot using any nutritional supplements in the three months prior to the study, and not having a sensitivity to creatine. |
| Soy | Placebo comparator | Dietary Supplement: soy proteinnot using any nutritional supplements in the three months prior to the study not having an allergy to soy protein |
| Placebo | No intervention | –Healthy men who do resistance training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 18-35 years old,
- Having regularly performed resistance training for at least one year,
- Not having any metabolic disease,
- Not taking any regular medication,
- Not using any nutritional supplements in the last three months prior to the study.
Key exclusion criteria (7 listed)
- Being between 18 and 35 years old,
- Having done resistance training for less than a year,
- Smoking and drinking alcohol,
- Taking regular medication,
- Having an allergy to soy protein,
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 |
|---|---|---|
| soy proteinThe first study to compare creatine supplementation. | Dietary supplement | Soy |
| Creatine MonohydrateThis is the first study to compare soy protein to a placebo. | Dietary supplement | CrM |
Primary outcome
Change in Body Composition Parameters (Skeletal Muscle Mass and Body Fat Percentage) Assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline and 8 weeks
Evaluated using a multi-frequency bioelectrical impedance analyzer to measure changes in skeletal muscle mass (kg) and body fat percentage (%) from baseline to the end of the 8-week intervention period.
Change in Serum Total Testosterone Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Baseline and 8 weeks
Evaluated via fasting blood serum analysis to determine changes in total testosterone concentrations from baseline to the end of the 8-week intervention period.
1 secondary outcome
Change in Serum Biomarkers of Muscle Damage (Creatine Kinase and Lactate Dehydrogenase) Assessed by Autoanalyzer
Time frame: Baseline and 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 30 Jul 2026.
- Results publication: PubMed 34444710Nieman DC. Current and Novel Reviews in Sports Nutrition. Nutrients. 2021 Jul 26;13(8):2549. doi: 10.3390/nu13082549.
- Results publication: PubMed 24605197Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
- Results publication: PubMed 30698725Churchward-Venne TA, Pinckaers PJM, Smeets JSJ, Peeters WM, Zorenc AH, Schierbeek H, Rollo I, Verdijk LB, van Loon LJC. Myofibrillar and Mitochondrial Protein Synthesis Rates Do Not Differ in Young Men Following the Ingestion of Carbohydrate with Milk Protein, Whey, or Micellar Casein after Concurrent Resistance- and Endurance-Type Exercise. J Nutr. 2019 Feb 1;149(2):198-209. doi: 10.1093/jn/nxy244.
- Results publication: PubMed 30952204Burke LM, Castell LM, Casa DJ, Close GL, Costa RJS, Desbrow B, Halson SL, Lis DM, Melin AK, Peeling P, Saunders PU, Slater GJ, Sygo J, Witard OC, Bermon S, Stellingwerff T. International Association of Athletics Federations Consensus Statement 2019: Nutrition for Athletics. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):73-84. doi: 10.1123/ijsnem.2019-0065. Epub 2019 Apr 5.
- Results publication: PubMed 31394788Berrazaga I, Micard V, Gueugneau M, Walrand S. The Role of the Anabolic Properties of Plant- versus Animal-Based Protein Sources in Supporting Muscle Mass Maintenance: A Critical Review. Nutrients. 2019 Aug 7;11(8):1825. doi: 10.3390/nu11081825.
- Results publication: PubMed 10356072Anthony JC, Anthony TG, Layman DK. Leucine supplementation enhances skeletal muscle recovery in rats following exercise. J Nutr. 1999 Jun;129(6):1102-6. doi: 10.1093/jn/129.6.1102.
- Results publication: PubMed 22876725Berg A, Schaffner D, Pohlmann Y, Baumstark MW, Deibert P, Konig D, Gollhofer A. A soy-based supplement alters energy metabolism but not the exercise-induced stress response. Exerc Immunol Rev. 2012;18:128-41.
- Results publication: PubMed 33665201Bassaganya-Riera J, Berry EM, Blaak EE, Burlingame B, le Coutre J, van Eden W, El-Sohemy A, German JB, Knorr D, Lacroix C, Muscaritoli M, Nieman DC, Rychlik M, Scholey A, Serafini M. Goals in Nutrition Science 2020-2025. Front Nutr. 2021 Feb 9;7:606378. doi: 10.3389/fnut.2020.606378. eCollection 2020.
- Individual participant dataSharing planned: Yes. All
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 soy protein and Creatine Monohydrate in people with Healthy Men Doing Resistance Training, run by Yakup Enes Çam at 1 site in Turkey (Türkiye).
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 5 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 30 Jul 2026. 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 Turkey (Türkiye). 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?
Change in Body Composition Parameters (Skeletal Muscle Mass and Body Fat Percentage) Assessed by Bioelectrical Impedance Analysis (BIA) (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07735988, which also lists 8 linked publications.
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 30 Jul 2026.