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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2025/10/095913 | Other Identifier | Clinical Trial Registry India |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cornfitâ„¢ | Experimental | Corn silk (Stigma maydis) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement | Dietary Supplement | active drug |
| |
| Placebo Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, Day 1, Day 42, Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr H N Shivaprasad Prasad | Botanic Healthcare Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raksha health care | Bangalore | Karnataka | 560119 | India |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Other |
placebo |
|
| 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 |
| 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. | 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. | 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. | 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. | Day 0, Day 0, Day 42, Day 84 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |