ObesityNCT03654391
Study of Obesity Control by Astragalus and Notoginseng Extrats
A study testing InnoSlim in people with Obesity, run by Chung Shan Medical University.
Trial summary
The effects of the Astragalus and Notoginseng extrats on obesity control was demonstrated in a randomized double-blind, and crossover human trial. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- 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
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 27 or body fat ≥ 30%;
- No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
- No drugs consumption.
Who cannot join
- BMI >35;
- Alcoholic;
- US-controlled diabetics;
- Stoke in past one year;
- High blood pressure;
- Mental diseases or melancholia;
- Pregency or breast-feeding a child.
About this study
The effects of the Astragalus and Notoginseng extrats on obesity control was demonstrated in a randomized double-blind, and crossover human trial.
Read the detailed description
Obesity refers to the body due to physiological or biochemical function of the change caused by excessive accumulation of body fat, resulting in weight gain. Hence, the aim of this study was to evaluate the effects of the Astragalus and Notoginseng extrats on obesity control by a randomized double-blind and crossover human trial. Subjects with simple obesity (body mass index (BMI) ≥ 27 or body fat ≥ 30%) ingested 5 extrats (n = 19) capsules or placebo (n = 19) perday for 12 weeks of a stage. Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every six weeks.
- Conditions
- Obesity
- Being tested
- InnoSlim, Placebo
- Keywords
- Astragalus and Notoginseng extrats, Body weight, BMI, Triglyceride, obese
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoSlimDietary supplement
Also called Astragalus and Notoginseng extrats
Subjects ingested 2 capsules (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.
PlaceboDietary supplement
Subjects ingested 2 capsules placebo in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.
| Study group | Role | What they receive |
|---|---|---|
| InnoSlim | Active comparator | Subjects ingested 2 capsules InnoSlim® (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Receives: Dietary Supplement: InnoSlim |
| Placebo | Placebo comparator | Subjects ingested 2 capsules placebo (Control group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of body weight and BMI of the subjects.
values change of body weight and BMI between before to after 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
The changes of triglyceride (TG) of the subjects
values change of triglyceride (TG) between before to after 12 weeks
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 posted31 Aug 2018
- Study startOct 2016
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
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
- irb@csh.org.tw Mr Shen, Ph.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654391
- Sponsor's protocol ID
- CS16098
- Status last verified
- Dec 2019
- First submitted
- 29 Aug 2018
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang W.L. et al. The inhibitory effect of ginse¬noside Rg1 on glucose and lipid production in human HepG2 cells. Adaptive Medicine. 2013, 5(4), 181-188.
Chang TC, Huang SF, Yang TC, Chan FN, Lin HC, Chang WL. Effect of ginsenosides on glucose uptake in human Caco-2 cells is mediated through altered Na+/glucose cotransporter 1 expression. J Agric Food Chem. 2007 Mar 7;55(5):1993-8. doi: 10.1021/jf062714k. Epub 2007 Feb 2.
PubMed 17269785Wang CW, Su SC, Huang SF, Huang YC, Chan FN, Kuo YH, Hung MW, Lin HC, Chang WL, Chang TC. An Essential Role of cAMP Response Element Binding Protein in Ginsenoside Rg1-Mediated Inhibition of Na+/Glucose Cotransporter 1 Gene Expression. Mol Pharmacol. 2015 Dec;88(6):1072-83. doi: 10.1124/mol.114.097352. Epub 2015 Oct 1.
PubMed 26429938
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Obesity Control by Astragalus and Notoginseng Extrats
- ClinicalTrials.gov ID
- NCT03654391
- Acronym / sponsor ID
- CS16098
- Conditions
- Obesity
- Keywords
- Astragalus and Notoginseng extrats, Body weight, BMI, Triglyceride, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 31 Aug 2018 (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 effects of the Astragalus and Notoginseng extrats on obesity control was demonstrated in a randomized double-blind, and crossover human trial.
Detailed description
Obesity refers to the body due to physiological or biochemical function of the change caused by excessive accumulation of body fat, resulting in weight gain. Hence, the aim of this study was to evaluate the effects of the Astragalus and Notoginseng extrats on obesity control by a randomized double-blind and crossover human trial. Subjects with simple obesity (body mass index (BMI) ≥ 27 or body fat ≥ 30%) ingested 5 extrats (n = 19) capsules or placebo (n = 19) perday for 12 weeks of a stage. Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every six weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InnoSlim | Active comparator | Dietary Supplement: InnoSlimSubjects ingested 2 capsules InnoSlim® (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects ingested 2 capsules placebo (Control group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥ 27 or body fat ≥ 30%;
- No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
- No drugs consumption.
Key exclusion criteria (7 listed)
- BMI >35;
- Alcoholic;
- US-controlled diabetics;
- Stoke in past one year;
- High blood pressure;
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 |
|---|---|---|
| InnoSlimAlso: Astragalus and Notoginseng extratsSubjects ingested 2 capsules (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks. | Dietary supplement | InnoSlim |
| PlaceboSubjects ingested 2 capsules placebo in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks. | Dietary supplement | Placebo |
Primary outcome
The changes of body weight and BMI of the subjects.
Time frame: 12 weeks
values change of body weight and BMI between before to after 12 weeks
1 secondary outcome
The changes of triglyceride (TG) of the subjects
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 16 Dec 2019.
- Results publicationChang W.L. et al. The inhibitory effect of ginse¬noside Rg1 on glucose and lipid production in human HepG2 cells. Adaptive Medicine. 2013, 5(4), 181-188.
- Results publication: PubMed 17269785Chang TC, Huang SF, Yang TC, Chan FN, Lin HC, Chang WL. Effect of ginsenosides on glucose uptake in human Caco-2 cells is mediated through altered Na+/glucose cotransporter 1 expression. J Agric Food Chem. 2007 Mar 7;55(5):1993-8. doi: 10.1021/jf062714k. Epub 2007 Feb 2.
- Results publication: PubMed 26429938Wang CW, Su SC, Huang SF, Huang YC, Chan FN, Kuo YH, Hung MW, Lin HC, Chang WL, Chang TC. An Essential Role of cAMP Response Element Binding Protein in Ginsenoside Rg1-Mediated Inhibition of Na+/Glucose Cotransporter 1 Gene Expression. Mol Pharmacol. 2015 Dec;88(6):1072-83. doi: 10.1124/mol.114.097352. Epub 2015 Oct 1.
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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.
irb@csh.org.tw Mr Shen, Ph.D. principal investigator
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A study testing InnoSlim in people with Obesity, run by Chung Shan Medical University.
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 7 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The changes of body weight and BMI of the subjects. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654391, which also lists 3 linked publications.
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 16 Dec 2019.