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

Primary Purpose

Hyperlipidemia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
InnoSlim®
Placebo
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

InnoSlim®

Arm Description

Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.

Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
December 11, 2019
Last Updated
August 13, 2020
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04201314
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.
Arm Title
InnoSlim®
Arm Type
Experimental
Arm Description
Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.
Intervention Type
Dietary Supplement
Intervention Name(s)
InnoSlim®
Intervention Description
Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.
Primary Outcome Measure Information:
Title
The changes of fasting blood glucose of the subjects
Description
A randomized-double blind, and crossover trial values change of fasting blood glucose between before to after0, 3, 6, 10, 13 & 16weeks
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
he changes of cholesterol of the subjects
Description
A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 & 16weeks
Time Frame
16 weeks
Title
he changes of triglyceride of the subjects
Description
A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 & 16weeks
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You-Cheng Mr Shen, Ph.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
402
Country
Taiwan

12. IPD Sharing Statement

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

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