Clinical trial NCT05483192: Impact of Oral Dyglomera™ on Body Fat and Blood Lipids of Overweight and Obese Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Body fat
Dyglomera
Blood lipids
Lead sponsor: Gateway Health Alliance
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Dyglomera on body fat of overweight and obese people
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of Dyglomera on blood cholesterol levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on blood triglyceride levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on fasting blood glucose levels
timeFrame: 12 weeks
measure: Effect of Dyglomera on CRP levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on ALT levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on AST levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on leptin levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on adiponectin levels of overweight and obese people
timeFrame: 12 weeks
measure: Effect of Dyglomera on blood insulin levels of overweight and obese people
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Specialty Hospital
state: Patparganj
Study officials:
References: