None listed
Conditions
Interventions
Intervention1: Group A: 1 sachet of FiberPrime Resistant Dextrin(25 g)sachet: Mixed in a 200ml of water for
30 days in the morning or evening before or after breakfast/lunch/dinner once daily.
Inter
Sponsors
NUTRA-AGRI INGREDIENTS LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females aged 18-60 years both inclusive. 2.Participants with no history of specific diet or medication intake that could interfere with metabolic homeostasis and gut microbiota, including but not limited to oral or intravenous antibiotics, probiotics, or other microbiota-altering supplements within three months prior to recruitment. 3.Trial participants in normal health as determined by personal medical history and clinical examination including vital signs. 4. Participants willing and able to maintain a habitual,balanced diet throughout the study period and providing voluntary, written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Participants with a diagnosis of colonic inertia. 2.Participants with a history of surgical interventions within the last six months. 3.History of anorectal surgery. 4.Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome , Inflammatory Bowel Disease , or chronic diarrhea. 5.Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture. 6.Participants with untreated or uncontrolled systemic conditions and comorbidities. 7.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status. 8.Participants using antibiotics, probiotic products, herbal supplements, dietary fiber, or phytonutrient supplements. 9. Participants following an abnormal or restrictive dietary pattern example low sodium, fasting, ketogenic, or high-protein diets during the four weeks preceding enrollment or unwilling to maintain a normal, balanced diet during the study period. 10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study. 11. Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1 or 2 pack per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effect of FiberPrime Resistant Dextrin on gastrointestinal symptoms as measured by change in Gastrointestinal Symptom Rating Scale (GSRS) score. 2. To assess stool consistency and frequency, time of evacuation, gut microbiome modulation and short-chain fatty acids analysis. Timepoint: 1.from baseline to day 30. 2.from baseline to day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Adverse events Profile. 2.Compliance and Tolerability of the investigational productTimepoint: 1.From baseline to Day 30. 2.From baseline to Day 30. | — |
Countries
India
Contacts
Public ContactDr Pankaj Nemade
Gunjkar Multispeciality Hospital
Outcome results
None listed