MedPath

To evaluate the effectiveness of DigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adults

Phase 2
Not yet recruiting
Conditions
Age between 30 to 60 years (Both inclusive)
Registration Number
CTRI/2023/10/058902
Lead Sponsor
Advanced Enzyme Technologies Ltd
Brief Summary

This prospective, randomized, double blind, placebo controlled, crossover study to evaluate the effect ofDigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adults. The trial will be conducted in adult male and female healthy volunteersbetween the age of 30 to 60 years (both inclusive) and having body mass index â‰¥ 30. Participants will be on study for amax. of 3 Months including wash out period.  The study aims to evaluate the effect ofDigeSEB Super PB on the postprandial nutrient level and to evaluate safety &tolerability of DigeSEB Super PB and its effect on gastro-intestinal symptomsand gut microbiota in healthy adults.  Statistical analysis will beperformed as listed in the protocol.

The enzymes included in investigationalproduct derived from non-animal sources and considered safe for humanconsumption. This product contains combination of enzymes (amylase, protease,lipase, cellulase, lactase, and hemicellulase) and probiotic strains (*B. coagulans, B. clausii, B. subtilis, L.plantarum* and *L. casei*); theseingredients are approved by FSSAI for nutraceutical use.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
36
Inclusion Criteria

1 Literate Male and female in equal ratio i e 18 in each group between the age of 30 to 60 years both inclusive 2 Participants determined by the PI as healthy participants with no known history of any disease or with complaints of any health aliment not prescribed with any medications and indicating good health with normal appetite normal physical and mental conditions 3 Participants willing to give written informed consent and adhere to all the requirements of this protocol.

Exclusion Criteria
  • 1.Pregnant and lactating female.
  • 2.Participants with BMI ≥ 30 3.Smokers and people who consume alcohol.
  • 4.Subject having known allergy to the ingredients in the test product.
  • 5.Known history of diabetes and hypertension.
  • 6.Participant having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Gastroesophageal reflux disease (GERD), Crohn’s disease, short bowel, ulcerative colitis, or irritable bowel syndrome (IBS).
  • 7.Participant has a history of bariatric surgery at any time before the Screening Visit.
  • 8.Participant has a history of any surgery in the past 3 months.
  • 9.Participant has a history of lactose intolerance.
  • 10.Participant on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems.
  • 11.Participant currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment.
  • 12.Participant currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening/enrollment.
  • 13.Participant currently taking or has in the past 30 days used GI related probiotics/prebiotics or any digestive enzymes [prescription or over the counter (OTC)].
  • 14.As per discretion/ judgement of the PI, subjects suspected with any medical condition during examination at screening.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Nutrient absorption (rate & concentration) in blood streamDay 30 and Day 90
Amino acid analysisDay 30 and Day 90
TriglyceridesDay 30 and Day 90
Total CholesterolDay 30 and Day 90
GlucoseDay 30 and Day 90
Secondary Outcome Measures
NameTimeMethod
1 Serum markersa Insulin

Trial Locations

Locations (2)

Sanjeevini Hospital

🇮🇳

Bangalore, KARNATAKA, India

Sri Laxmi Hospital

🇮🇳

Bangalore, KARNATAKA, India

Sanjeevini Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Shruti N Kulkarni
Principal investigator
9731600196
shruti.nk666@gmail.com

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