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

Sponsor

Gateway Health Alliance (Industry)

Overall Status

Completed

CT.gov ID

NCT05483192

Collaborator

(none)

120

Enrollment

Location

Arms

4.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Fat Disorder	Dietary Supplement: Oral Dyglomera	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera

Masking:

Double (Participant, Care Provider)

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2021

Actual Primary Completion Date :

Jun 12, 2021

Actual Study Completion Date :

Jun 18, 2021

Arms and Interventions

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

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Effect of Dyglomera on body fat of overweight and obese people [12 weeks]
DEXA and impedance measurement of body fat

Secondary Outcome Measures

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 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 ALT levels of overweight and obese people [12 weeks]
Blood assay to measure ALT
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Max Super Specialty Hospital	New Delhi	Patparganj	India	110092

Sponsors and Collaborators

Gateway Health Alliance

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gateway Health Alliance

ClinicalTrials.gov Identifier:

NCT05483192

Other Study ID Numbers:

2021/11/049204

First Posted:

Aug 2, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gateway Health Alliance

Body fat

Dyglomera

Blood lipids

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Aug 2, 2022