The impact of co-administration of probiotic with plant protein on protein absorption

The impact of co-administration of probiotic Bacillus coagulans Unique IS2 with plant protein on post-prandial protein absorption in young adults - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059599

Enrollment

Registered

2023-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotic with pea protein: One sachet of 2 billion CFU Bacillus coagulans and 25 gm pea protein daily for 15 days orally Control Intervention1: Pea protein: One sachet of 25 gm pea pr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Normal and healthy male between 18-25 years age group 2. Subject is willing and able to comply with the protocol and diet 3. Is willing to refrain from eating any yogurt or lacto-fermented beverages during the study 4. Is willing to refrain from using any dietary supplements or nutritionals during the study 5. Not taking any 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. If a subject has had any stomach or intestinal surgery (i.e. gastric bypass). 4. Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems. 5. Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment. 6. Subject currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within 60 days prior to screening/enrollment. 7. 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)]. 8. Subject having known allergy to the ingredients in the test product.

Design outcomes

Primary

Measure	Time frame
Total amino acidsTimepoint: Amino acids would be assessed at baseline (0 day; before starting the supplementation) and after 2 weeks (four time points at 14th day: 0 min, 60 min, 120 min, 180 min and 240 min after ingestion for post-prandial analysis)	—

Secondary

Measure	Time frame
?-amino nitrogen (AAN) , total nitrogen (TN), serum urea, urinary creatinine and ureaTimepoint: at baseline (0 day) and first sample of 2 weeks (0 min sample of 14th day)	—

Countries

India

Contacts

Public ContactDr Ransi Ann Abraham

All India Institute of Medical Sciences

ransijob@gmail.com26594426

Outcome results