Overweight and ObesityNCT03973086
To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
A study testing Citrus flavonone-O-glycosides- LD and Citrus flavonone-O-glycosides- HD in people with Overweight and Obesity, run by Vedic Lifesciences Pvt. Ltd. at 1 site in United States.
Trial summary
CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Citrus flavonone-O-glycosides- LD and Citrus flavonone-O-glycosides- HD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 18 Sep 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants with the age of ≥18 and ≤ 60 years of age.
- BMI of ≥25 - ≤ 35 kg/m2
- Waist circumference:India: Men: > 94 cm (37 inches), Women: >80 cm (31.5 inches) USA: Men: > 102 cm (40 inches), Women: >89 cm (35 inches)
- Triglycerides >150 mg/dL
- Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
- Fasting blood glucose ≥ 100 mg/ dl
- Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL
- Ready to give voluntary, written, informed consent to participate in the study.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the trial:
- Current smoker.
- Inability to walk independently.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Neurological conditions causing functional or cognitive impairments
- Unwillingness or inability to be randomized to one of three intervention groups.
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- Bilateral hip replacements.
- Exposure to any non-registered drug product within 3 months prior to the screening visit.
- Unable/unwillingness to complete study specific diaries (digital/paper-based).
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 CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program.
This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.
- Conditions
- Overweight and Obesity
- Being tested
- Citrus flavonone-O-glycosides- LD, Citrus flavonone-O-glycosides- HD, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus flavonone-O-glycosides- LDDietary supplement
Low Dose of 200 mg
Citrus flavonone-O-glycosides- HDDietary supplement
High Dose of 400 mg
PlaceboDietary supplement
Placebo (Microcrystalline Cellulose) of 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Citrus flavonone-O-glycosides (Low dose) | Experimental | Not described Receives: Dietary Supplement: Citrus flavonone-O-glycosides- LD |
| Citrus flavonone-O-glycosides (High dose) | Experimental | Not described Receives: Dietary Supplement: Citrus flavonone-O-glycosides- HD |
| Microcrystaline Cellulose- 400mg | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat percent Body Mass Index (kg/m2)
Assessed using DEXA
Measured: 16 weeks.
Change in Lean Body Mass (g)
Assessed using DEXA
Measured: 16 weeks
Change in Body Fat (%)
Assessed using DEXA
Measured: 16 weeks
Change in Fat Free Mass (g)
Assessed using DEXA
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start4 Jun 2019
- Primary completion30 May 2020
- Study completion18 Sep 2020
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973086
- Sponsor's protocol ID
- HP/190201/CITRUSLIM/BCMH
- Status last verified
- Jun 2019
- First submitted
- 7 May 2019
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. 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 CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT03973086
- Acronym / sponsor ID
- HP/190201/CITRUSLIM/BCMH
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 4 Jun 2019 (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.
CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program.
This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Citrus flavonone-O-glycosides (Low dose) | Experimental | Dietary Supplement: Citrus flavonone-O-glycosides- LD |
| Citrus flavonone-O-glycosides (High dose) | Experimental | Dietary Supplement: Citrus flavonone-O-glycosides- HD |
| Microcrystaline Cellulose- 400mg | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female participants with the age of ≥18 and ≤ 60 years of age.
- BMI of ≥25 - ≤ 35 kg/m2
- Waist circumference:India: Men: > 94 cm (37 inches), Women: >80 cm (31.5 inches) USA: Men: > 102 cm (40 inches), Women: >89 cm (35 inches)
- Triglycerides >150 mg/dL
- Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
Key exclusion criteria (9 listed)
- Current smoker.
- Inability to walk independently.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Neurological conditions causing functional or cognitive impairments
- Unwillingness or inability to be randomized to one of three intervention groups.
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 |
|---|---|---|
| Citrus flavonone-O-glycosides- LDLow Dose of 200 mg | Dietary supplement | Citrus flavonone-O-glycosides (Low dose) |
| Citrus flavonone-O-glycosides- HDHigh Dose of 400 mg | Dietary supplement | Citrus flavonone-O-glycosides (High dose) |
| PlaceboPlacebo (Microcrystalline Cellulose) of 400 mg | Dietary supplement | Microcrystaline Cellulose- 400mg |
Primary outcome
Change in body fat percent Body Mass Index (kg/m2)
Time frame: 16 weeks.
Assessed using DEXA
Change in Lean Body Mass (g)
Time frame: 16 weeks
Assessed using DEXA
Change in Body Fat (%)
Time frame: 16 weeks
Assessed using DEXA
Change in Fat Free Mass (g)
Time frame: 16 weeks
Assessed using DEXA
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 12 Apr 2021.
- Individual participant dataSharing planned: No
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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 Citrus flavonone-O-glycosides- LD and Citrus flavonone-O-glycosides- HD in people with Overweight and Obesity, run by Vedic Lifesciences Pvt. Ltd. at 1 site in United States.
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 8 inclusion and 9 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 12 Apr 2021. 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 United States. 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 fat percent Body Mass Index (kg/m2) (time frame: 16 weeks.). The study lists 4 primary outcomes in all. 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 12 Apr 2021.