Body Fat DisorderDyglomeraNCT05483192
Impact of Oral Dyglomera™ on Body Fat and Blood Lipids of Overweight and Obese Adults
A study testing Oral Dyglomera in people with Body Fat Disorder, run by Gateway Health Alliance at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder
- What is being tested?
- Oral Dyglomera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 12 Feb 2021to 18 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Body Fat Disorder
- Being tested
- Oral Dyglomera
- Keywords
- Body fat, Dyglomera, Blood lipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral DyglomeraDietary supplement
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Oral Dyglomera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dyglomera on body fat of overweight and obese people
DEXA and impedance measurement of body fat
Measured: 12 weeks
Secondary outcomes (10)
Effect of Dyglomera on blood cholesterol levels of overweight and obese people
Blood assay to measure blood total cholesterol
Measured: 12 weeks
Effect of Dyglomera on blood triglyceride levels of overweight and obese people
Blood assay to measure blood total triglycerides
Measured: 12 weeks
Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people
Blood assay to measure HDL-cholesterol
Measured: 12 weeks
Effect of Dyglomera on fasting blood glucose levels
Blood assay to measure fasting blood glucose
Measured: 12 weeks
Effect of Dyglomera on CRP levels of overweight and obese people
Blood assay to measure CRP
Measured: 12 weeks
Effect of Dyglomera on ALT levels of overweight and obese people
Blood assay to measure ALT
Measured: 12 weeks
Effect of Dyglomera on AST levels of overweight and obese people
Blood assay to measure blood AST
Measured: 12 weeks
Effect of Dyglomera on leptin levels of overweight and obese people
Blood assay to measure leptin
Measured: 12 weeks
Effect of Dyglomera on adiponectin levels of overweight and obese people
Blood assay to measure blood adiponectin
Measured: 12 weeks
Effect of Dyglomera on blood insulin levels of overweight and obese people
Blood assay to measure insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start12 Feb 2021
- Primary completion12 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gateway Health Alliance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483192
- Sponsor's protocol ID
- 2021/11/049204
- Acronym
- Dyglomera
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05483192
- Acronym / sponsor ID
- Dyglomera / 2021/11/049204
- Conditions
- Body Fat Disorder
- Keywords
- Body fat, Dyglomera, Blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gateway Health AllianceIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera
| Arm | Type | Receives |
|---|---|---|
| Comparison between placebo and active treatment | Placebo comparator | Dietary Supplement: Oral Dyglomera120 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. |
| Comparison of baseline to final outcome | Active comparator | Dietary Supplement: Oral DyglomeraThe effect of Dyglomera on body fat and blood parameters were compared at baseline and at the end of the intervention period. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral DyglomeraAlso: PlaceboMeasurement 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. | Dietary supplement | Comparison between placebo and active treatment, Comparison of baseline to final outcome |
Primary outcome
Effect of Dyglomera on body fat of overweight and obese people
Time frame: 12 weeks
DEXA and impedance measurement of body fat
10 secondary outcomes
Effect of Dyglomera on blood cholesterol levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on blood triglyceride levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on fasting blood glucose levels
Time frame: 12 weeks
Effect of Dyglomera on CRP levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on ALT levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on AST levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on leptin levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on adiponectin levels of overweight and obese people
Time frame: 12 weeks
Effect of Dyglomera on blood insulin levels of overweight and obese people
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Dyglomera in people with Body Fat Disorder, run by Gateway Health Alliance at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Dyglomera on body fat of overweight and obese people (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.