CClinicalTrials.gg
Status unknownNCT04201314Updated Aug 14, 2020

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

An interventional study of InnoSlim® and Placebo in Hyperlipidemia, sponsored by Chung Shan Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-14.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperlipidemia

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03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's planned enrollment of 12 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • Placebo comparator
    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.

    Dietary Supplement: InnoSlim® · Dietary Supplement: Placebo

  • Experimental
    InnoSlim®

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

    Dietary Supplement: InnoSlim® · Dietary Supplement: Placebo

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 16 weeks

Secondary outcomes

  1. 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

    Time frame: 16 weeks

  2. 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

    Time frame: 16 weeks

07

Study locations

1 site
  • Chung Shan Medical University
    Taichung, 402, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04201314
Lead sponsor
Chung Shan Medical University
Responsible party
You-Cheng Shen (Department of Health Diet and Industry Management, Chung Shan Medical University) — Principal investigator
First posted
Dec 17, 2019
Start date
Nov 8, 2019
Primary completion
Jun 30, 2020
Completion
Sep 30, 2020 (estimated)
Last update
Aug 14, 2020

Study contacts

You-Cheng Mr Shen, Ph.D.
principal investigator · Chung Shan Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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