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

NCT04201314 | Unknown DMC

• 1 other identifier: CS2-19062
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Outcome Measures

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

  16 weeks

Secondary Outcomes (2)

• he changes of cholesterol of the subjects

  16 weeks

• he changes of triglyceride of the subjects

  16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

InnoSlim®

EXPERIMENTAL

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

InnoSlim® DIETARY_SUPPLEMENT

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

InnoSlim®; Placebo

Placebo 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®; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• You-Cheng Mr Shen, Ph.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Health Diet and Industry Management

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: November 8, 2019
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

TW (1)