HyperlipidemiaNCT04201314
Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans
A study testing InnoSlim® in people with Hyperlipidemia, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
InnoSlim® has been studied for enhancing metabolic functions whereas many lab studies have demonstrated the potential efficacy of InnoSlim® for the blood sugar and blood lipids regulation. There has been no relevant human study on InnoSlim® on blood sugar and blood lipids regulation. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- InnoSlim®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Nov 2019to 30 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants age 20 years and above.
- Participant has provided written and dated informed consent to participate in the study.
- Participant is willing and able to comply with the study.
- Participants blood sugar (100≤ fasting blood glucose ≤ 125 mg/dL and 5.7%≤HbA1c ≤ 6.4% ) and Total cholesterol ≥200 mg/dL
Who cannot join
- Participant is participating in another clinical trial thirty days prior to enrollment.
- Participant has a significant history or current presence of treated or untreated heart disease, kidney disease, liver disease, muscle disease, bone disease, or a history of surgery.
- Participant has any medical condition or uses any medication, nutritional product, dietary supplement or program which might interfere with the conduct of the study or place the subject at risk.
- Participants lost to follow-up, non-compliance, concomitant medication.
Trial locations and contacts
1 site in 1 country.
About this study
InnoSlim® has been studied for enhancing metabolic functions whereas many lab studies have demonstrated the potential efficacy of InnoSlim® for the blood sugar and blood lipids regulation. There has been no relevant human study on InnoSlim® on blood sugar and blood lipids regulation. There have reported that 2018 estimating the total costs of diagnosed diabetes have risen to $327 billion in 2017 from $245 billion in 2012. Although pharmacological methods have been developed to treat diabetes, these treatments can be costly and are not without potential adverse effects. The development of dietary agents for the prevention of diabetes could represent a cost-effective and safe means to deal with this growing public health crisis.
Read the detailed description
In this study, the investigators are investigating the effects of InnoSlim® on blood sugar and blood lipids regulation in humans. The testing sample is orally administrated to participants with pre-diabetes and hyperlipidemia humans, the efficacy parameters of blood sugar, lipid profile and other parameters, as well as adverse effects to the healthy individual, are screened during the trial, the significant difference is shown and no adverse effect reported.
- Conditions
- Hyperlipidemia
- Being tested
- InnoSlim®, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoSlim®Dietary supplement
Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.
PlaceboDietary supplement
Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage. Receives: Dietary Supplement: InnoSlim®; Dietary Supplement: Placebo |
| InnoSlim® | Experimental | Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage. Receives: Dietary Supplement: InnoSlim®; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of fasting blood glucose of the subjects
A randomized-double blind, and crossover trial values change of fasting blood glucose between before to after0, 3, 6, 10, 13 \& 16weeks
Measured: 16 weeks
Secondary outcomes (2)
he changes of cholesterol of the subjects
A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 \& 16weeks
Measured: 16 weeks
he changes of triglyceride of the subjects
A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 \& 16weeks
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 posted17 Dec 2019
- Study start8 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Cheng Shen, Chung Shan Medical University
- Investigators
- You-Cheng Mr Shen, Ph.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201314
- Sponsor's protocol ID
- CS2-19062
- Status last verified
- Aug 2020
- First submitted
- 11 Dec 2019
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans
- ClinicalTrials.gov ID
- NCT04201314
- Acronym / sponsor ID
- CS2-19062
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 17 Dec 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.
InnoSlim® has been studied for enhancing metabolic functions whereas many lab studies have demonstrated the potential efficacy of InnoSlim® for the blood sugar and blood lipids regulation. There has been no relevant human study on InnoSlim® on blood sugar and blood lipids regulation. There have reported that 2018 estimating the total costs of diagnosed diabetes have risen to $327 billion in 2017 from $245 billion in 2012. Although pharmacological methods have been developed to treat diabetes, these treatments can be costly and are not without potential adverse effects. The development of dietary agents for the prevention of diabetes could represent a cost-effective and safe means to deal with this growing public health crisis.
Detailed description
In this study, the investigators are investigating the effects of InnoSlim® on blood sugar and blood lipids regulation in humans. The testing sample is orally administrated to participants with pre-diabetes and hyperlipidemia humans, the efficacy parameters of blood sugar, lipid profile and other parameters, as well as adverse effects to the healthy individual, are screened during the trial, the significant difference is shown and no adverse effect reported.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: InnoSlim®, Dietary Supplement: PlaceboSubjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage. |
| InnoSlim® | Experimental | Dietary Supplement: InnoSlim®, Dietary Supplement: PlaceboSubjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants age 20 years and above.
- Participant has provided written and dated informed consent to participate in the study.
- Participant is willing and able to comply with the study.
- Participants blood sugar (100≤ fasting blood glucose ≤ 125 mg/dL and 5.7%≤HbA1c ≤ 6.4% ) and Total cholesterol ≥200 mg/dL
Key exclusion criteria (4 listed)
- Participant is participating in another clinical trial thirty days prior to enrollment.
- Participant has a significant history or current presence of treated or untreated heart disease, kidney disease, liver disease, muscle disease, bone disease, or a history of surgery.
- Participant has any medical condition or uses any medication, nutritional product, dietary supplement or program which might interfere with the conduct of the study or place the subject at risk.
- Participants lost to follow-up, non-compliance, concomitant medication.
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 |
|---|---|---|
| InnoSlim®Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage. | Dietary supplement | InnoSlim®, Placebo |
| PlaceboSubjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage. | Dietary supplement | InnoSlim®, Placebo |
Primary outcome
The changes of fasting blood glucose of the subjects
Time frame: 16 weeks
A randomized-double blind, and crossover trial values change of fasting blood glucose between before to after0, 3, 6, 10, 13 \& 16weeks
2 secondary outcomes
he changes of cholesterol of the subjects
Time frame: 16 weeks
he changes of triglyceride of the subjects
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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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.
You-Cheng Mr Shen, Ph.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnoSlim® in people with Hyperlipidemia, run by Chung Shan Medical University at 1 site in Taiwan.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. 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 Taiwan. 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?
Results are not available in the source record.
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?
The changes of fasting blood glucose of the subjects (time frame: 16 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 14 Aug 2020.