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

NCT ID: NCT04201314

Last Updated: 2020-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

InnoSlim®

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

InnoSlim®

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

Group Type EXPERIMENTAL

InnoSlim®

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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InnoSlim®

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

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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You-Cheng Shen

Department of Health Diet and Industry Management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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You-Cheng Mr Shen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS2-19062

Identifier Type: -

Identifier Source: org_study_id

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