None listed
Conditions
Interventions
Intervention1: Bacillus Coagulans: 2 billion Bacillus Coagulans with 20 gm whey protein/day, orally
Intervention2: Bacillus Clausii: 2 billion Bacillus Clausii with 20 grams whey protein/day orally
C
Sponsors
unique biotech
Eligibility
Inclusion criteria
Inclusion criteria: Normal and healthy male Subject is willing and able to comply with the protocol and diet Attending gym regularly Is willing to refrain from eating any yogurt or lacto fermented beverages during the study Is willing to refrain from using any dietary supplements or nutritionals during the study Not taking any new vitamin and/or mineral supplements for last 3 months
Exclusion criteria
Exclusion criteria: 1. Subject having any medical conditions 2. Subject having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Cohn’s disease, short bowel, ulcerative colitis, or Irritable Bowel Syndrome (IBS). 3. Subject is lactose intolerant (self-professed or diagnosed). 4. If a subject has had any stomach or intestinal surgery (i.e. gastric bypass). 5. Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems. 6. Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment. 7. Subject currently taking antibiotics (or any drug that significantly interferes With bacterial flora) or has taken antibiotics Within the 60 days prior to screening/enrollment. 8. Subject currently taking or has in the past 30 days used probiotics/prebiotics (including yogurt and lacto-fermented beverages) or any digestive enzymes [prescription or over-the-counter (OTC)]. 9. Subject having known allergy to the ingredients in the test product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| protein absorption and utilizationTimepoint: 30 days, 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Body composition of the subjects. ii. Measures of perceived gastrointestinal health and upper respiratory health of the subjects. iii. muscle strength, girth and performance. iv. Cardio respiratory fitness. v. Oxidative stress and antioxidant status of the subjects. Timepoint: 60 days | — |
Countries
India
Contacts
Public ContactNidhi Bhatia Sachdev
All India Institute of Medical Sciences
Outcome results
None listed