Body Fat Reduction and Weight Management (NCT07378033) | Clinical Trial Compass
By InvitationNot Applicable
Body Fat Reduction and Weight Management
India100 participantsStarted 2025-10-23
Plain-language 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.
Who can participate
Age range19 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in total body fat mass assessed by DEXA at 12 weeks
. 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.