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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Bitlis Eren Üniversites

    Bitlis, 13000

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07735988
Study groupRoleWhat they receive
CrMPlacebo comparatorNot using any nutritional supplements in the three months prior to the study, and not having a sensitivity to creatine.
Receives: Dietary Supplement: Creatine Monohydrate
SoyPlacebo comparatornot using any nutritional supplements in the three months prior to the study not having an allergy to soy protein
Receives: Dietary Supplement: soy protein
PlaceboNo interventionHealthy men who do resistance training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  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.

  1. First posted30 Jul 2026
  2. Study start5 Jan 2026
  3. Primary completion2 Feb 2026
  4. Study completion2 Mar 2026

Resources

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)
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 34444710
  • Kim 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 24605197
  • Churchward-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 30698725
  • Burke 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 30952204
  • Berrazaga 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 31394788
  • Anthony 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 10356072
  • Berg 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 22876725
  • Bassaganya-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

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.

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