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

NCT05483192 | Completed

• 1 other identifier: 2021/11/049204
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Fat Disorder

Keywords

Body fat; Dyglomera; Blood lipids

Outcome Measures

Primary Outcomes (1)

• Effect of Dyglomera on body fat of overweight and obese people

  DEXA and impedance measurement of body fat

  12 weeks

Secondary Outcomes (10)

• Effect of Dyglomera on blood cholesterol levels of overweight and obese people

  12 weeks

• Effect of Dyglomera on blood triglyceride levels of overweight and obese people

  12 weeks

• Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people

  12 weeks

• Effect of Dyglomera on fasting blood glucose levels

  12 weeks

• Effect of Dyglomera on CRP levels of overweight and obese people

  12 weeks

Study Arms (2)

Comparison between placebo and active treatment

PLACEBO COMPARATOR

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

Comparison of baseline to final outcome

ACTIVE COMPARATOR

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

Interventions

Oral Dyglomera DIETARY_SUPPLEMENT

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.

Also known as: Placebo

Comparison between placebo and active treatment; Comparison of baseline to final outcome

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• Patients that has an age below 19 years old and greater than 65 years old,
• Patients not available for the study period,

Sponsors & Collaborators

• Gateway Health Alliance: lead

Study Sites (1)

Max Super Specialty Hospital

New Delhi, Patparganj, 110092, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 2, 2022
• Study Start: February 12, 2021
• Primary Completion: June 12, 2021
• Study Completion: June 18, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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)

Locations

IN (1)