None listed
Conditions
Interventions
Intervention1: DigeSEB Super PB: Dose: 400 mg capsule
Dosage form: Capsule
Frequency: Two Capsules, Twice a day
(2 capsules just after lunch + 2 capsules just after dinner)
Route of administration: Or
Sponsors
Advanced Enzyme Technologies Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutrient absorption (rate & concentration) in blood stream Amino acid analysis Triglycerides Total Cholesterol Glucose Timepoint: Day 30 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Serum markers a Insulin b HbA1c 2 Questionnaire and Scales a Post prandial Hunger and Satiety scale b Gastrointestinal Symptom Questionnaire 3 Serum markers SGOT SGPT Serum creatinine blood urea nitrogen BUN total albumin and globulin 4 Microbiota analysis in an equally distributed sub population of 10 participants 5 Product tolerability a Tolerability to investigation product 6 Rate of incidence of AE and SAEsTimepoint: 1 Serum markers a Day 30 and Day 90 b Baseline Day 30 Day 61 and Day 90 2 Questionnaire and Scales a Day 1 Day 7 Day 15 Day 21 Day 30 Day 61 Day 67 Day 75 Day 81 and Day 90 b Day 1 Day 30 Day 61 and day 90 3 Serum markers Baseline Day 30 and Day 90 4 Microbiota analysis Day 30 and Day 90 5 Product tolerability Day 30 and Day 90 6 Throughout the study | — |
Countries
India
Contacts
Public ContactDr Sujay Gowda
Advanced Enzyme Technologies Ltd
Outcome results
None listed