Body Fat Disorder
Conditions
Keywords
Body fat, Dyglomera, Blood lipids
Brief summary
The extract of Dichrostachys glomerata (DyglomeraTM), has been reported to be effective in weight reduction in obese patients with metabolic syndrome. This plant has been shown to have many biological properties and has been reported to have no toxic or adverse side effects in animals. The purpose of this human study was to prove that the effect of reducing body fat percentage (%) after 12 weeks of intake was superior to that of the control group.
Detailed description
This is a 12-weeks randomized double-blind placebo controlled trial. 120 number of subjects are planned. Each subject will be administered a single dose of the investigational product once daily, before lunch or dinner, consisting each time of 400 mg of the test product or placebo. Subjects will be assigned to the test group or placebo group in random order. Evaluations will be taken at baseline and at the beginning of each of the 5 study visits. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. The following investigational products will be used: * Test product: Dichrostachys glomerata extract (Dyglomera™) at a dose of 400 mg * Control product: Placebo at a dose of 400 mg In this human study, starting with Visit 2, the duration of participation in the human study will be 12 weeks (84 days) in total. The study period will be planned to be 8 months from the date of approval of the human study. The screening visit of the first subject will be conducted at the MAX SPECIALTY HOSPITAL, and the first subject will be enrolled thereafter. The last subject will complete the study within about 5 months.
Interventions
DIETARY_SUPPLEMENTOral Dyglomera
Measurement of body weight, waist circumference, hip circumference, waist to hip ratio, body mass index, body fat. Blood draw and measurement of blood total Cholesterol, HDL-cholesterol, LDL-cholesterol), ALT, AST, Fasting Blood Glucose, CRP, adiponectin, and leptin.
Sponsors
Gateway Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
To maintain double-blinding, in addition to the contents mentioned in the production/packaging and labeling of the products used in the human study, the allocation details of unique codes (information on blinding) for each group will be managed in a sealed state by the principal investigator. Except in cases where it is unavoidably necessary to read the code due to the occurrence of a serious adverse drug reaction\*, it will not be disclosed until the end of the human study. In this human study, no unblinding will occur during the study. The investigator will supply the investigational products that match the randomization code assigned to the selected subject, and maintain blinding by using an extra (by unique code) when the investigational product is defective or damaged.
Intervention model description
12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged from 19 to 65 years old, * Patients with a BMI ranging between 25 and 34.9 kg/m2, * Patients available for the entire period of study .
Exclusion criteria
* Patients that has an age below 19 years old and greater than 65 years old, * Patients not available for the study period, * Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Dyglomera on body fat of overweight and obese people | 12 weeks | DEXA and impedance measurement of body fat |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Dyglomera on blood triglyceride levels of overweight and obese people | 12 weeks | Blood assay to measure blood total triglycerides |
| Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people | 12 weeks | Blood assay to measure HDL-cholesterol |
| Effect of Dyglomera on fasting blood glucose levels | 12 weeks | Blood assay to measure fasting blood glucose |
| Effect of Dyglomera on CRP levels of overweight and obese people | 12 weeks | Blood assay to measure CRP |
| Effect of Dyglomera on blood cholesterol levels of overweight and obese people | 12 weeks | Blood assay to measure blood total cholesterol |
| Effect of Dyglomera on AST levels of overweight and obese people | 12 weeks | Blood assay to measure blood AST |
| Effect of Dyglomera on leptin levels of overweight and obese people | 12 weeks | Blood assay to measure leptin |
| Effect of Dyglomera on adiponectin levels of overweight and obese people | 12 weeks | Blood assay to measure blood adiponectin |
| Effect of Dyglomera on blood insulin levels of overweight and obese people | 12 weeks | Blood assay to measure insulin |
| Effect of Dyglomera on ALT levels of overweight and obese people | 12 weeks | Blood assay to measure ALT |
Countries
India
Outcome results
None listed