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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-12

Study Completion Date

2021-06-18

Brief Summary

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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.

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Detailed Description

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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

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Body Fat Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Oral Dyglomera

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Oral Dyglomera

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo

Eligibility Criteria

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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 .