Obesity & OverweightNCT07378033
Body Fat Reduction and Weight Management
A study testing Dietary Supplement in people with Obesity & Overweight, run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
Trial summary
Obesity is a chronic complex disease defined by excessive fat deposits that can impair health. Obesity can lead to increased risk of type 2 diabetes and heart disease, it can affect bone health and reproduction, it increases the risk of certain cancers. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Dietary Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 23 Oct 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males and non-pregnant females aged 19 to 65 years
- Individuals with a BMI of 25-32kg/m2 who are not taking any obesity related medicines.
- Able to comply with all required study procedures and schedule.
- Able to comply and willing to follow the prescribed diet plan.
- Willing and able to give written informed consent.
Who cannot join
- Individuals who experienced a weight change of 5% or more within 3 months prior to the screening.
- Individuals who have taken or used medications, herbal remedies, or health supplements (including probiotics) for anti- obesity purposes (e.g., energy metabolism, appetite suppression, weight control, fat breakdown, carbohydrate blocking, inhibition of fat absorption, or gastrointestinal activity regulation) within 6 months prior to the screening.
- Individuals who have participated in or experienced a weight-loss program within 3 months prior to the screening.
- Individuals with Gastrointestinal disease like Crohn's Disease, Inflammatory Bowel Syndrome, Gastric resection, Chronic Inflammation (Kidney, Liver, Pancreas), infectious diseases, Autoimmune diseases, Malabsorption syndrome, Porphyria, Hepatitis B or C carriers.
- Individuals currently using immunosuppressants; proton pump inhibitors (PPIs), H2 receptor blockers, or nonsteroidal anti-inflammatory drugs (NSAIDs); insulin; thyroid hormone replacement therapy.
- Individuals who have taken Appetite suppressants, Semaglutide, OTC weight loss supplements 3 to 6 months before the trial.
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- Individuals who have consistently consumed dietary supplements (including protein supplements), teas, beverages, or jellies for weight control or fat reduction purposes.
- Individuals who have undergone any obesity surgery or any surgery within the last 6 months.
- Individuals who have consistently taken medications or health supplements for cholesterol improvement or blood circulation enhancement within 6 months prior to the screening.
- Individuals who have clinically significant diseases or disorders related to the liver, kidneys, pancreas, biliary system, cardiovascular system, respiratory system, endocrine system (e.g., diabetes, thyroid disorders), or central nervous system, or who have malignant tumors as identified in physical or clinical examinations (except those who have not experienced recurrence for over 5 years post-surgery).
- Individuals with uncontrolled hypertension (systolic blood pressure greater or equal to 160 mmHg or diastolic blood pressure greater or equal to 100 mmHg).
- Individuals diagnosed with diabetes and taking medications to control blood sugar.
- Individuals undergoing psychiatric medication or psychotherapy for eating disorders or other mental disorders.
- Individuals with a history of clinically significant hypersensitivity reactions or those who may exhibit hypersensitivity to the ingredients or similar components of the investigational product.
- Individuals who have consistently used functional products for cellulite removal or fat breakdown.
- Heavy smokers (greater or equal to 20 cigarettes/day).
- Individuals who excessively consume alcohol (greater or equal to 40 g/day for men or greater or equal to20 g/day for women).
- Individuals whose diagnostic or medical test results at the screening visit show the following AST, ALT, or gamma GTP levels exceeding three times the upper limit of the laboratory reference range. eGFR less 60 mL/min/1.73 m square.
- Individuals who have participated in other clinical trials or human application studies within 3 months prior to the screening.
- Pregnant or lactating women or within 6 months of giving birth
- Individuals deemed unsuitable for participation in the study by the principal investigator based on diagnostic laboratory results or other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Cornfit™ for Body Fat Reduction and Weight Management
Obesity is a chronic complex disease defined by excessive fat deposits that can impair health. Obesity can lead to increased risk of type 2 diabetes and heart disease, it can affect bone health and reproduction, it increases the risk of certain cancers. Obesity influences the quality of living, such as sleeping or moving. The diagnosis of overweight and obesity is made by measuring people's weight and height and by calculating the body mass index (BMI): weight kg/height² m². The body mass index is a surrogate marker of fatness and additional measurements, such as the waist circumference, can help the diagnosis of obesity. The BMI categories for defining obesity vary by age and gender in infants, children and adolescents. Corn silk also known as Stigma maydis is a type of agricultural waste composed of a long, silky, hair-like structure ranging from yellowish to reddish in colour. In vitro and in vivo studies of corn silk showed adipogenesis, lipid metabolism and body weight management. Additionally, it reduces and inhibits adipose tissue formation and reduces the size of adipocytes and prevents excess fat accumulation. The anti-obesity effect of maize silk extract decreases the absorption of dietary fat and suppresses the formation of fatty acids. Corn silk inhibits the expression of adipogenic transcription factors like the peroxisome proliferator-activated receptor gamma and CCAAT/enhancer-binding proteins C/EBPs and prevents the differentiation of pre-mature adipocytes into mature adipocytes, it also suppresses the development of adipose tissue and the accumulation of excess fat.
- Conditions
- Obesity & Overweight
- Being tested
- Dietary Supplement, Placebo Control
- Keywords
- Weight management
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
active drug
Placebo ControlOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Cornfit™ | Experimental | Corn silk (Stigma maydis) Receives: Dietary Supplement: Dietary Supplement |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total body fat mass assessed by DEXA at 12 weeks
Change in total body fat mass from baseline to Week 12, measured using dual-energy X-ray absorptiometry (DEXA), comparing the intervention and placebo groups
Measured: Day 0, Day 1, Day 42, Day 84
Secondary outcomes (6)
Change in regional body fat mass by body area assessed by DEXA at 12 weeks
Change in regional body fat mass from baseline to Week 12 in the whole body, arms, legs, trunk, android, and gynoid regions, measured using dual-energy X-ray absorptiometry (DEXA), comparing the intervention and placebo groups.
Measured: Day 0, Day 1, Day 42, Day 84
Change in total body fat percentage assessed by DEXA at 12 weeks
Change in total body fat percentage from baseline to Week 12, measured using dual-energy X-ray absorptiometry (DEXA), comparing the intervention and placebo groups
Measured: Day 0, Day 1, Day 42, Day 84
Change in lean mass percentage assessed by DEXA at 12 weeks
Change in lean mass percentage from baseline to Week 12, measured using dual-energy X-ray absorptiometry (DEXA), comparing the intervention and placebo groups.
Measured: Day 0, Day 1, Day 42, Day 84
Change in total abdominal fat area assessed by abdominal CT at 12 weeks
Change in total abdominal fat area from baseline to Week 12, measured using abdominal computed tomography (CT), comparing the intervention and placebo groups.
Measured: Day 0, Day 1, Day 42, Day 84
Change in subcutaneous fat area assessed by abdominal CT at 12 weeks
Change in subcutaneous fat area from baseline to Week 12, measured using abdominal computed tomography (CT), comparing the intervention and placebo groups.
Measured: Day 0, Day 1, Day 42, Day 84
Change in visceral fat area assessed by abdominal CT at 12 weeks
Change in visceral fat area from baseline to Week 12, measured using abdominal computed tomography (CT), comparing the intervention and placebo groups.
Measured: Day 0, Day 0, Day 42, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start23 Oct 2025
- Primary completion10 Apr 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr H N Shivaprasad Prasad, Study director, Botanic Healthcare Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378033
- Sponsor's protocol ID
- BSP-25-075
- Other IDs
- CTRI/2025/10/095913
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Cornfit™ for Body Fat Reduction and Weight Management
- ClinicalTrials.gov ID
- NCT07378033
- Acronym / sponsor ID
- BSP-25-075
- Conditions
- Obesity & Overweight
- Keywords
- Weight management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a chronic complex disease defined by excessive fat deposits that can impair health. Obesity can lead to increased risk of type 2 diabetes and heart disease, it can affect bone health and reproduction, it increases the risk of certain cancers. Obesity influences the quality of living, such as sleeping or moving. The diagnosis of overweight and obesity is made by measuring people's weight and height and by calculating the body mass index (BMI): weight kg/height² m². The body mass index is a surrogate marker of fatness and additional measurements, such as the waist circumference, can help the diagnosis of obesity. The BMI categories for defining obesity vary by age and gender in infants, children and adolescents. Corn silk also known as Stigma maydis is a type of agricultural waste composed of a long, silky, hair-like structure ranging from yellowish to reddish in colour. In vitro and in vivo studies of corn silk showed adipogenesis, lipid metabolism and body weight management. Additionally, it reduces and inhibits adipose tissue formation and reduces the size of adipocytes and prevents excess fat accumulation. The anti-obesity effect of maize silk extract decreases the absorption of dietary fat and suppresses the formation of fatty acids. Corn silk inhibits the expression of adipogenic transcription factors like the peroxisome proliferator-activated receptor gamma and CCAAT/enhancer-binding proteins C/EBPs and prevents the differentiation of pre-mature adipocytes into mature adipocytes, it also suppresses the development of adipose tissue and the accumulation of excess fat.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cornfit™ | Experimental | Dietary Supplement: Dietary SupplementCorn silk (Stigma maydis) |
| Placebo | Placebo comparator | Other: Placebo ControlPlacebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult males and non-pregnant females aged 19 to 65 years
- Individuals with a BMI of 25-32kg/m2 who are not taking any obesity related medicines.
- Able to comply with all required study procedures and schedule.
- Able to comply and willing to follow the prescribed diet plan.
- Willing and able to give written informed consent.
Key exclusion criteria (21 listed)
- Individuals who experienced a weight change of 5% or more within 3 months prior to the screening.
- Individuals who have taken or used medications, herbal remedies, or health supplements (including probiotics) for anti- obesity purposes (e.g., energy metabolism, appetite suppression, weight control, fat breakdown, carbohydrate blocking, inhibition of fat absorption, or gastrointestinal activity regulation) within 6 months prior to the screening.
- Individuals who have participated in or experienced a weight-loss program within 3 months prior to the screening.
- Individuals with Gastrointestinal disease like Crohn's Disease, Inflammatory Bowel Syndrome, Gastric resection, Chronic Inflammation (Kidney, Liver, Pancreas), infectious diseases, Autoimmune diseases, Malabsorption syndrome, Porphyria, Hepatitis B or C carriers.
- Individuals currently using immunosuppressants; proton pump inhibitors (PPIs), H2 receptor blockers, or nonsteroidal anti-inflammatory drugs (NSAIDs); insulin; thyroid hormone replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplementactive drug | Dietary supplement | Cornfit™ |
| Placebo Controlplacebo | Other | Placebo |
Primary outcome
Change in total body fat mass assessed by DEXA at 12 weeks
Time frame: Day 0, Day 1, Day 42, Day 84
Change in total body fat mass from baseline to Week 12, measured using dual-energy X-ray absorptiometry (DEXA), comparing the intervention and placebo groups
6 secondary outcomes
Change in regional body fat mass by body area assessed by DEXA at 12 weeks
Time frame: Day 0, Day 1, Day 42, Day 84
Change in total body fat percentage assessed by DEXA at 12 weeks
Time frame: Day 0, Day 1, Day 42, Day 84
Change in lean mass percentage assessed by DEXA at 12 weeks
Time frame: Day 0, Day 1, Day 42, Day 84
Change in total abdominal fat area assessed by abdominal CT at 12 weeks
Time frame: Day 0, Day 1, Day 42, Day 84
Change in subcutaneous fat area assessed by abdominal CT at 12 weeks
Time frame: Day 0, Day 1, Day 42, Day 84
Change in visceral fat area assessed by abdominal CT at 12 weeks
Time frame: Day 0, Day 0, Day 42, Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr H N Shivaprasad Prasad study director
Botanic Healthcare Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with Obesity & Overweight, run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total body fat mass assessed by DEXA at 12 weeks (time frame: Day 0, Day 1, Day 42, Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.