None listed
Conditions
Interventions
Intervention1: Standard protein mix and Probiotic containing B. coagulans: 1 to 2 sachet to be taken orally with water once daily, at approximately the same time each day, preferably morning and night
Sponsors
Abode Biotec India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject has provided written and dated informed consent to participate in the study. 2. Subject is willing and able to comply with the protocol. 3. Healthy male/female of age 18-60 years. 4. Subject is in good health as determined by a health history questionnaire. 5. Subject ready to follow the diet and exercise regime. 6. Subject is untrained in resistance/power exercise
Exclusion criteria
Exclusion criteria: 1. Subject on protein and/ or probiotic rich diet. 2. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrolment. 3. Subject has a history of alcohol or other drug abuse in the past year 4. Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP > 140 and/or diastolic BP > 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. 5. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study. 6. Subject has a known allergy or sensitivity to any ingredient in the test product. 7. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 8. Subject has a history of difficulty swallowing large pills or tablets 9. Subject has a history of orthopaedic injury or surgery within the last year. 10. Subject has any physical condition considered a contraindication to the type of exercise performed in the study. 11. Subject has had an abnormal resting ECG. 12. Investigator is uncertain about subjectââ?¬•s capability or willingness to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the Creatine Kinase and CRP levels between the intervention group and the placebo group Timepoint: Time Frame: baseline Day 0, week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in muscle soreness pain VAS between the intervention group and the placebo group over the study period.Timepoint: Time Frame: baseline (Day 1, wk 4, wk 8] | — |
Countries
India
Contacts
Public ContactDivya C
Bio Agile Therapeutics Pvt. Ltd
Outcome results
None listed