None listed
Conditions
Interventions
Intervention1: Bacillus coagulans BCP92 : Bacillus coagulans BCP92 probiotic at a dose of 2 billion CFU per day, administered orally once daily, in combination with Whey Protein Concentrate (WCP) 25g
Sponsors
Pellucid Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male participants aged 18-35 years (both inclusive) at the time of informed consent. 2. Normal body mass index (BMI) 19.0-24.99 kg.m at screening. 3. Participants engaging in regular structured resistance training at a gymnasium or fitness facility for at least 3 months prior to screening, with a minimum frequency of 4 days per week. 4. Willingness and ability to comply with the study protocol, including dietary restrictions, exercise regimen, and scheduled study visits. 5. Willingness to abstain from all dietary supplements, nutritional products, and ergogenic aids (excluding study-provided whey protein and investigational product) for the duration of the study. 6. Non-smokers and non-consumers of alcohol (defined as less than 2 standard drinks per week) for at least 6 months prior to screening. 7. Ability to provide written informed consent after receiving detailed explanation of the study procedures, potential risks, and benefits. 8. Willingness to maintain consistent dietary intake and exercise routine throughout the study duration.
Exclusion criteria
Exclusion criteria: 1. History of or currently suffering from any diagnosed gastrointestinal disease or inflammatory bowel condition including but not limited to Crohn disease, Ulcerative colitis, Irritable bowel syndrome, Short bowel syndrome, Celiac disease, or Gastroesophageal reflux disease requiring daily medication. 2. History of stomach or intestinal surgery excluding uncomplicated appendectomy or hernia repair more than 12 months prior. 3. Self reported or diagnosed lactose intolerance or milk protein allergy. 4. Current use of medications for diarrhea, constipation, heartburn, or other gastrointestinal problems more than one dose per week in the past month. 5. Current use or use within 30 days prior to screening of laxatives, stool softeners, or antidiarrheal medications. 6. Current use or use within 60 days prior to screening of systemic antibiotics, antifungal medications, or any medication that significantly interferes with intestinal bacterial flora. 7. Current use or use within 30 days prior to screening of probiotics including dietary sources such as yogurt, kefir, kombucha, kimchi, or sauerkraut, prebiotics including inulin or fructooligosaccharides, digestive enzymes whether prescription or over the counter, protein supplements other than study provided whey protein, creatine, beta alanine, or other performance enhancing supplements. 8. Known allergy or hypersensitivity to any ingredient in the investigational product Bacillus coagulans or maltodextrin or whey protein concentrate. 9. Systolic blood pressure less than 100 millimeters of mercury or greater than 140 millimeters of mercury at screening. 10. Diastolic blood pressure less than 60 millimeters of mercury or greater than 90 millimeters of mercury at screening. 11. Resting heart rate less than 60 beats per minute or greater than 100 beats per minute at screening assessed after five minutes of seated rest. 12. History of significant cardiovascular disease including myocardial infarction, angina, heart failure, or arrhythmia requiring treatment. 13. Diagnosed diabetes mellitus Type 1 or Type 2 or glycated hemoglobin 7.0 percent or higher at screening. 14. Diagnosed hypertension requiring pharmacological treatment. 15. History of renal impairment or estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters at screening. 16. History of hepatic impairment or liver transaminases alanine aminotransferase or aspartate aminotransferase greater than two times the upper limit of normal at screening. 17. Any chronic medical condition that in the opinion of the investigator would interfere with study participation or assessment of endpoints. 18. History of malignancy within the past five years excluding successfully treated basal cell carcinoma or squamous cell carcinoma of the skin. 19. Participation in another clinical trial within 30 days prior to screening or concurrent participation in any other clinical study. 20. Any condition or circumstance that in the opinion of the investigator would compromise the participant ability to comply with the study protocol or confound the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in plasma free amino acid concentrations (total amino acids, essential amino acids, branched-chain amino acids).Timepoint: Baseline, Day 30, and Day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in muscular strength assessed by one-repetition maximum (1RM) testing (bench press, leg press, and deadlift). Mean change in muscle hypertrophy and body composition parameters, including skinfold thickness and body mass index (BMI). Mean change in oxidative stress and inflammatory biomarkers, including serum creatine kinase (CK), high-sensitivity C-reactive protein (hs-CRP), and fasting serum insulin levels. Mean change in gastrointestinal-related quality of life assessed using the SF-36 health survey questionnaire. Safety and tolerability assessed by the incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs), changes in vital signs, and laboratory safety parameters (haematology, hepatic, and renal function tests)Timepoint: Baseline, Day 30, and Day 60 | — |
Countries
India
Contacts
Public ContactDr. Sohel Shaikh
Eccentric Clinical Research Private Limited
Outcome results
None listed