NCT05483192

Impact of Oral Dyglomera™ on Body Fat and Blood Lipids of Overweight and Obese Adults

Evaluation the Impact of Oral Dichrostachys Glomerata Extract (Dyglomera™) in Overweight and Obese Adults for Reducing Body Fat and Modulating Blood Parameters a Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Gateway Health Alliance · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Fat Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral 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.

Timeline

• Start date: 2021-02-12
• Primary completion: 2021-06-12
• Completion: 2021-06-18
• First posted: 2022-08-02
• Last updated: 2022-08-02

Locations

1 site across 1 country: India