Hyperlipidemia
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTInnoSlim®
Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.
DIETARY_SUPPLEMENTPlacebo
Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of fasting blood glucose of the subjects | 16 weeks | A randomized-double blind, and crossover trial values change of fasting blood glucose between before to after0, 3, 6, 10, 13 & 16weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| he changes of cholesterol of the subjects | 16 weeks | A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 & 16weeks |
| he changes of triglyceride of the subjects | 16 weeks | A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 & 16weeks |
Countries
Taiwan
Outcome results
None listed