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CTRI Number  CTRI/2026/01/100264 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 01/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Food and Nutraceutical]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of Soluble Fibre Supplementation in gut health and gastrointestinal Tolerability. 
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Gastrointestinal Tolerability, Prebiotic Effects, and Gut Health Benefits of FiberPrime®. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/25-26/020 Version: 2.00; Dated 10-December-2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj Nemade 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital  
Address  Gunjkar Multispeciality Hospital, Plot No 315, Sector No 18,Spine Road,Chinchwad,
-
Pune
MAHARASHTRA
411062
India 
Phone  8087521353  
Fax  -  
Email  drpankaj.gunjkarhopsital@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Nemade 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital  
Address  Gunjkar Multispeciality Hospital, Plot No 315, Sector No 18,Spine Road,Chinchwad,
-
Pune
MAHARASHTRA
411062
India 
Phone  8087521353  
Fax  -  
Email  drpankaj.gunjkarhopsital@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Nemade 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital  
Address  Gunjkar Multispeciality Hospital, Plot No 315, Sector No 18,Spine Road,Chinchwad,
-
Pune
MAHARASHTRA
411062
India 
Phone  8087521353  
Fax  -  
Email  drpankaj.gunjkarhopsital@gmail.com  
 
Source of Monetary or Material Support  
NUTRA-AGRI INGREDIENTS LLC,4220 S MARYLAND PKWY 2ND FL, STE 200, LAS VEGAS, NV 89119, USA  
 
Primary Sponsor  
Name  NUTRA-AGRI INGREDIENTS LLC 
Address  4220 S MARYLAND PKWY 2ND FL, STE 200, LAS VEGAS, NV 89119, USA 
Type of Sponsor  Other [Food business] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pankaj Nemade  Gunjkar Multispeciality Hospital  OPD No.3,Ground floor,Spine road ,Shivtej Nagar,chinchwad
Pune
MAHARASHTRA 		 8087521353
-
drpankaj.gunjkarhopsital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No history of specific diet or medication intake  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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. 
Intervention  Group B: 1 sachet of FiberPrime® Resistant Dextrin(50 g)sachet  Mixed in a 200ml of water for 30 days in the morning or evening before or after breakfast/lunch/dinner once daily. 
Comparator Agent  Group C: 1 sachet of Placebo (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.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.
 		 1.from baseline to day 30.
2.from baseline to day 30.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Adverse events Profile.
2.Compliance and Tolerability of the investigational product  		 1.From baseline to Day 30.
2.From baseline to Day 30.
 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/01/2026 
Date of Study Completion (India) 21/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Recent research shows that gut bacteria play an important role in metabolic conditions like obesity, diabetes, and IBS. Soluble and resistant fibres, including resistant dextrins, help improve gut health by supporting good bacteria and increasing short-chain fatty acids (SCFAs), which protect the gut and support metabolism. Tapioca-based resistant dextrin (TRD) is a gentle, fermentable fibre that reaches the colon, promotes probiotic growth, and produces beneficial SCFAs. Studies suggest that TRD can help lower post-meal blood sugar and insulin without causing major digestive discomfort. Although resistant fibres show promise for improving metabolism and gut balance, human studies are still limited, and gender differences are not well understood. This study will test two doses (25 g and 50 g) of tapioca-derived soluble fibre versus placebo for 30 days in healthy adults to evaluate its effects on digestion, stool pattern, gut microbiome, Short Chain Fatty Acids, and overall tolerability. 
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