Overweight and ObesityObesityNCT04611477
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
A study testing Rice Hulk, Synbiotic365 Ver 5 and Synbiotic365 Ver 7 in people with Overweight and Obesity, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
Evaluate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition (Body Mass… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Rice Hulk, Synbiotic365 Ver 5 and Synbiotic365 Ver 7
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- 28 Sep 2020to 29 Oct 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants aged ≥30 and ≤60 years.
- Participants with a BMI in the range of ≥25 to 34.9 kg/m2.
- Normal levels of SGOT and SGPT i.e. up to 2.5 times of upper limit of reference range.
- Normal level of Creatinine i.e. up to 1.5 times of upper limit of reference range.
- 5 Alkaline Phosphatase i.e. up to 1.5 times of upper limit of reference range
- 6. Participants having At least 3 of the following five metabolic risk factors: i. Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches) ii. Triglycerides levels >150 mg/dL iii. Blood pressure ≥130 mm Hg (systolic, SBP) and/or ≥85 mm Hg(diastolic, DBP); iv. Fasting blood glucose ≥ 100 mg/ dL v. Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL..
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- 7. Participants willing to complete all the study procedures including study-related questionnaires and comply with the study requirements.
- 8. Participants willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
- 9. Participants ready to give voluntary, written, informed consent to participate in the study.
- 10. Participants willing to continue the same diet and exercise regime throughout the study period.
Who cannot join
- Individuals having a history of smoking or currently smoking and also using any form of tobacco preparations.
- Participants diagnosed with type II diabetes mellitus or undiagnosed cases of hyperglycemia with fasting blood sugar > 170 mg/dl.
- Participants with blood pressure ≥150 mm Hg (systolic, SBP) and/or ≥ 99 mm Hg (diastolic, DBP)
- Inability to walk independently
- History of significant weight instability (defined as > 2 kg of weight loss over last 3 months)
- Participants currently on diuretics, metformin or thyroid supplements. Presence of unstable, acutely symptomatic, or life-limiting illness.
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- Any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- 8 Unwillingness or inability to be randomized to any one of the three intervention groups.
- 9 Continuous participation in randomly assigned lifestyle intervention program for six months.
- 10 Bilateral hip replacements.
- 11 Unable to give consent.
- 12 Known cases of hypothyroidism.
- 13 Abnormal TSH value, out of reference range (<0.4μIU/mL and > 4.0μIU/mL).
- 14 Females with the history of irregular menses or any other gynecological disorder such as (polycystic ovarian syndrome (PCOS), hormonal disturbances, etc).
- 15 History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic disorders, that in the judgment of the investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Synbiotic 365 on Body Composition in Overweight and Obese Individuals.
Evaluate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition (Body Mass Index, Lean Body Mass, Body Fat, Fat Free Mass).
- Conditions
- Overweight and Obesity
- Being tested
- Rice Hulk, Synbiotic365 Ver 5, Synbiotic365 Ver 7
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice HulkOther
Placebo
Synbiotic365 Ver 5Other
Active Comparator
Synbiotic365 Ver 7Other
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One capsule/day to be taken orally 30 minutes before breakfast Receives: Other: Rice Hulk |
| Synbiotic365 Ver 5 | Active comparator | One capsule/day to be taken orally 30 minutes before breakfast Receives: Other: Synbiotic365 Ver 5 |
| Synbiotic365 Ver 7 | Active comparator | One capsule/day to be taken orally 30 minutes before breakfast Receives: Other: Synbiotic365 Ver 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI) and the percentage of body fat f
To investigate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition
Measured: Day 0 (Baseline) to Day 84
Secondary outcomes (10)
• Total body weight change in comparison to placebo on day 28, 56 and 84, from baseline, as assessed by weighing scale method.
Measured: Day 0 (Baseline) to Day 84
• Change in central obesity in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the anthropometric index of waist-to-hip ratio.
Measured: Day 0 (Baseline) to Day 84
• Change in coronary risk in comparison to placebo on day 84 from baseline.
Measured: Day 0 (Baseline) to Day 84
• Change in blood glucose metabolism in comparison to placebo on day 84 from baseline as assessed by HOMA-IR [(fasting Glucose x fasting Insulin) /405)].
Measured: Day 0 (Baseline) to Day 84
• Change in systemic inflammation in comparison to placebo on day 84 from baseline as assessed by hs-CRP test.
Measured: Day 0 (Baseline) to Day 84
• Change in health-related quality of life (HRQL) scores in comparison to placebo on day 28, 56 and 84 from baseline, as assessed by Gastrointestinal Quality of Life Index (GIQLI).
Measured: Day 0 (Baseline) to Day 84
• Change in satiety in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the Three-Factor Eating Questionnaire (TFEQ) for satiety.
Measured: Day 0 (Baseline) to Day 84
• The change in vital signs monitoring on all the study visits from baseline.
Measured: Day 0 (Baseline) to Day 84
• The change in liver and renal safety parameters.
Measured: Day 0 (Baseline) to Day 84
• Adverse and serious adverse events recorded during the study duration on IP consumption, as compared to placebo.
Measured: Day 0 (Baseline) to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start28 Sep 2020
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parag Dr. Salvi, MD, Principal investigator, Shri Madhumadhav Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611477
- Sponsor's protocol ID
- NI/190701/SYNBIOTIC365/OO
- Acronym
- Obesity
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Synbiotic 365 on Body Composition in Overweight and Obese Individuals.
- ClinicalTrials.gov ID
- NCT04611477
- Acronym / sponsor ID
- Obesity / NI/190701/SYNBIOTIC365/OO
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 2 Nov 2020 (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.
Evaluate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition (Body Mass Index, Lean Body Mass, Body Fat, Fat Free Mass).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Rice HulkOne capsule/day to be taken orally 30 minutes before breakfast |
| Synbiotic365 Ver 5 | Active comparator | Other: Synbiotic365 Ver 5One capsule/day to be taken orally 30 minutes before breakfast |
| Synbiotic365 Ver 7 | Active comparator | Other: Synbiotic365 Ver 7One capsule/day to be taken orally 30 minutes before breakfast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female participants aged ≥30 and ≤60 years.
- Participants with a BMI in the range of ≥25 to 34.9 kg/m2.
- Normal levels of SGOT and SGPT i.e. up to 2.5 times of upper limit of reference range.
- Normal level of Creatinine i.e. up to 1.5 times of upper limit of reference range.
- 5 Alkaline Phosphatase i.e. up to 1.5 times of upper limit of reference range
Key exclusion criteria (15 listed)
- Individuals having a history of smoking or currently smoking and also using any form of tobacco preparations.
- Participants diagnosed with type II diabetes mellitus or undiagnosed cases of hyperglycemia with fasting blood sugar > 170 mg/dl.
- Participants with blood pressure ≥150 mm Hg (systolic, SBP) and/or ≥ 99 mm Hg (diastolic, DBP)
- Inability to walk independently
- History of significant weight instability (defined as > 2 kg of weight loss over last 3 months)
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 |
|---|---|---|
| Rice HulkPlacebo | Other | Placebo |
| Synbiotic365 Ver 5Active Comparator | Other | Synbiotic365 Ver 5 |
| Synbiotic365 Ver 7Active Comparator | Other | Synbiotic365 Ver 7 |
Primary outcome
Change in body mass index (BMI) and the percentage of body fat f
Time frame: Day 0 (Baseline) to Day 84
To investigate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition
10 secondary outcomes
• Total body weight change in comparison to placebo on day 28, 56 and 84, from baseline, as assessed by weighing scale method.
Time frame: Day 0 (Baseline) to Day 84
• Change in central obesity in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the anthropometric index of waist-to-hip ratio.
Time frame: Day 0 (Baseline) to Day 84
• Change in coronary risk in comparison to placebo on day 84 from baseline.
Time frame: Day 0 (Baseline) to Day 84
• Change in blood glucose metabolism in comparison to placebo on day 84 from baseline as assessed by HOMA-IR [(fasting Glucose x fasting Insulin) /405)].
Time frame: Day 0 (Baseline) to Day 84
• Change in systemic inflammation in comparison to placebo on day 84 from baseline as assessed by hs-CRP test.
Time frame: Day 0 (Baseline) to Day 84
• Change in health-related quality of life (HRQL) scores in comparison to placebo on day 28, 56 and 84 from baseline, as assessed by Gastrointestinal Quality of Life Index (GIQLI).
Time frame: Day 0 (Baseline) to Day 84
• Change in satiety in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the Three-Factor Eating Questionnaire (TFEQ) for satiety.
Time frame: Day 0 (Baseline) to Day 84
• The change in vital signs monitoring on all the study visits from baseline.
Time frame: Day 0 (Baseline) to Day 84
• The change in liver and renal safety parameters.
Time frame: Day 0 (Baseline) to Day 84
• Adverse and serious adverse events recorded during the study duration on IP consumption, as compared to placebo.
Time frame: Day 0 (Baseline) to Day 84
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 Feb 2022.
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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.
Parag Dr. Salvi, MD principal investigator
Shri Madhumadhav Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice Hulk, Synbiotic365 Ver 5 and Synbiotic365 Ver 7 in people with Overweight and Obesity, run by Vedic Lifesciences Pvt. Ltd. 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 10 inclusion and 15 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 Feb 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?
Change in body mass index (BMI) and the percentage of body fat f (time frame: Day 0 (Baseline) to Day 84). 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 Feb 2022.