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NCT07378033Enrolling by invitation

Body Fat Reduction and Weight Management

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Cornfit™ for Body Fat Reduction and Weight Management

Source: ClinicalTrials.gov · Last updated 30 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
100 (estimated)
First submitted
2 Jan 2026
Start date
23 Oct 2025
Primary completion date
10 Apr 2026
Lead sponsor
Bioagile Therapeutics Pvt. Ltd.
Diseases
Obesity
NCT number
NCT07378033

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 23 Oct 2025 to the primary completion date, 10 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.
  • 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 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 participated in other clinical trials or human application studies within 3 months prior to the screening.

Other illness

  • 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 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.

Lab values

  • 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 deemed unsuitable for participation in the study by the principal investigator based on diagnostic laboratory results or other reasons

Other

  • Individuals who have consistently consumed dietary supplements (including protein supplements), teas, beverages, or jellies for weight control or fat reduction purposes.
  • 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).
  • Pregnant or lactating women or within 6 months of giving birth

Who the study is looking for

  • 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.

Age in the registry: 19 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Raksha health care
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.