Clinical trial NCT04201314: Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans
Official title: Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemia
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The changes of fasting blood glucose of the subjects
timeFrame: 16 weeks
Secondary outcomes:
measure: he changes of cholesterol of the subjects
timeFrame: 16 weeks
measure: he changes of triglyceride of the subjects
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: You-Cheng Mr Shen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: