Effects of Soy Protein and Creatine Supplementation on Certain Parameters in Men Performing Resistance Exercise

NCT07735988 | Completed DMC

• 1 other identifier: 2025/1327
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Men Doing Resistance Training

Keywords

Creatine; Soy protein; Resistance Training; Body Composition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Change in Serum Biomarkers of Muscle Damage (Creatine Kinase and Lactate Dehydrogenase) Assessed by Autoanalyzer

  Baseline and 8 weeks

Study Arms (3)

CrM

PLACEBO COMPARATOR

Not using any nutritional supplements in the three months prior to the study, and not having a sensitivity to creatine.

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

Dietary Supplement: soy protein

Placebo

NO INTERVENTION

Healthy men who do resistance training.

Interventions

soy protein DIETARY_SUPPLEMENT

The first study to compare creatine supplementation.

Soy

Creatine Monohydrate DIETARY_SUPPLEMENT

This is the first study to compare soy protein to a placebo.

CrM

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yakup Enes Çam: lead

Study Sites (1)

Bitlis Eren Üniversites

Bitlis, 13000, Turkey (Türkiye)

Location

Related Publications (8)

• Nieman DC. Current and Novel Reviews in Sports Nutrition. Nutrients. 2021 Jul 26;13(8):2549. doi: 10.3390/nu13082549.

  PMID: 34444710 RESULT

• 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.

  PMID: 24605197 RESULT

• 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.

  PMID: 30698725 RESULT

• 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.

  PMID: 30952204 RESULT

• 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.

  PMID: 31394788 RESULT

• 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.

  PMID: 10356072 RESULT

• 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.

  PMID: 22876725 RESULT

• 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.

  PMID: 33665201 RESULT

MeSH Terms

Interventions

Soybean Proteins; Creatine

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Guanidines; Amidines; Organic Chemicals; Amino Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 30, 2026
• Study Start: January 5, 2026
• Primary Completion: February 2, 2026
• Study Completion: March 2, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 29.04.2026-29.04.2028
• Access Criteria: Everyone

Locations

TU (1)