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

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

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.

Study Overview

• Status: Completed
• Conditions: Body Fat Disorder
• Intervention / Treatment: Dietary supplement: Oral Dyglomera

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Patparganj
    • New Delhi, Patparganj, India, 110092
      • Max Super Specialty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria included: morbid obesity (BMI > 34.9 kg/m2); diabetes mellitus requiring daily insulin management; pregnancy/lactation; active infection; and systemic disease such as HIV/AIDS, active hepatitis or clinical signs of active malignancy within the past 5 years. Other exclusion criteria will include having taken any other medications or any natural health product within 1 month prior to the screening visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Comparison between placebo and active treatment; 120 subjects were planned. Screening data was reviewed to determine subject eligibility. Subjects who met all inclusion criteria and none of the exclusion criteria were enrolled into the study. The following investigational products were used: Test product: Dichrostachys glomerata extract (Dyglomera™) at a dose of 400 mg; Control product: Placebo at a dose of 400 mg Subjects were assigned to the test group or placebo group in random order. Each subject was administered a single 400 mg dose of Dyglomera or placebo once daily, before lunch or dinner. Measurements were taken at baseline and at the beginning of each of the 5 study visits.	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.; Other Names: Placebo
Active Comparator: Comparison of baseline to final outcome; The effect of Dyglomera on body fat and blood parameters were compared at baseline and at the end of the intervention period.	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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Dyglomera on body fat of overweight and obese people	DEXA and impedance measurement of body fat	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Dyglomera on blood cholesterol levels of overweight and obese people	Blood assay to measure blood total cholesterol	12 weeks
Effect of Dyglomera on blood triglyceride levels of overweight and obese people	Blood assay to measure blood total triglycerides	12 weeks
Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people	Blood assay to measure HDL-cholesterol	12 weeks
Effect of Dyglomera on fasting blood glucose levels	Blood assay to measure fasting blood glucose	12 weeks
Effect of Dyglomera on CRP levels of overweight and obese people	Blood assay to measure CRP	12 weeks
Effect of Dyglomera on ALT levels of overweight and obese people	Blood assay to measure ALT	12 weeks
Effect of Dyglomera on AST levels of overweight and obese people	Blood assay to measure blood AST	12 weeks
Effect of Dyglomera on leptin levels of overweight and obese people	Blood assay to measure leptin	12 weeks
Effect of Dyglomera on adiponectin levels of overweight and obese people	Blood assay to measure blood adiponectin	12 weeks
Effect of Dyglomera on blood insulin levels of overweight and obese people	Blood assay to measure insulin	12 weeks

Collaborators and Investigators

• Sponsor: Gateway Health Alliance

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): June 12, 2021
• Study Completion (Actual): June 18, 2021

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Blood lipids; Body fat; Dyglomera
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2021/11/049204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in the management of overweight and obese people. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No