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

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ClinicalTrials.gov Identifier: NCT04201314
Recruitment Status : Unknown
Verified August 2020 by You-Cheng Shen, Chung Shan Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : December 17, 2019
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
You-Cheng Shen, Chung Shan Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: InnoSlim® Dietary Supplement: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans
Actual Study Start Date : November 8, 2019
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Glucose

Arms and Interventions
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Arm Intervention/treatment
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®
Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.

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

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.


Outcome Measures
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Primary Outcome Measures :
  1. The changes of fasting blood glucose of the subjects [ Time Frame: 16 weeks ]
    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 :
  1. he changes of cholesterol of the subjects [ Time Frame: 16 weeks ]
    A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 & 16weeks

  2. he changes of triglyceride of the subjects [ Time Frame: 16 weeks ]
    A randomized-double blind, and crossover trial values change of blood lipid between before to after0, 3, 6, 10, 13 & 16weeks


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201314


Locations
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Taiwan
Chung Shan Medical University
Taichung, Taiwan, 402
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: You-Cheng Mr Shen, Ph.D. Chung Shan Medical University
More Information
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Responsible Party: You-Cheng Shen, Department of Health Diet and Industry Management, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT04201314    
Other Study ID Numbers: CS2-19062
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases