Body Fat Reduction and Weight Management

NCT07378033 | Enrolling By Invitation

• 2 other identifiers: BSP-25-075CTRI/2025/10/095913
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Weight management

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Day 0, Day 1, Day 42, Day 84

• Change in total body fat percentage assessed by DEXA at 12 weeks

  Day 0, Day 1, Day 42, Day 84

• Change in lean mass percentage assessed by DEXA at 12 weeks

  Day 0, Day 1, Day 42, Day 84

• Change in total abdominal fat area assessed by abdominal CT at 12 weeks

  Day 0, Day 1, Day 42, Day 84

• Change in subcutaneous fat area assessed by abdominal CT at 12 weeks

  Day 0, Day 1, Day 42, Day 84

Study Arms (2)

Cornfit™

EXPERIMENTAL

Corn silk (Stigma maydis)

Dietary Supplement: Dietary Supplement

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo Control

Interventions

Placebo Control OTHER

placebo

Placebo

Dietary Supplement DIETARY_SUPPLEMENT

active drug

Cornfit™

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bioagile Therapeutics Pvt. Ltd.: lead

Study Sites (1)

Raksha health care

Bangalore, Karnataka, 560119, India

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr H N Shivaprasad Prasad

  Botanic Healthcare Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 30, 2026
• Study Start: October 23, 2025
• Primary Completion: April 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)