Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans

Hyperlipidemia Clinical Trial

Official title:

Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04201314
• Other study ID #: CS2-19062
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 8, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2020
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• InnoSlim®
Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.
• Placebo
Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 weeks
Secondary	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	16 weeks
Secondary	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	16 weeks