NCT03654391

Brief Summary

The effects of the Astragalus and Notoginseng extrats on obesity control was demonstrated in a randomized double-blind, and crossover human trial.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

August 29, 2018

Last Update Submit

December 13, 2019

Conditions

Obesity

Keywords

Astragalus and Notoginseng extratsBody weightBMITriglycerideobese

Outcome Measures

Primary Outcomes (1)

  • The changes of body weight and BMI of the subjects.

    values change of body weight and BMI between before to after 12 weeks

    12 weeks

Secondary Outcomes (1)

  • The changes of triglyceride (TG) of the subjects

    12 weeks

Study Arms (2)

InnoSlim

ACTIVE COMPARATOR

Subjects ingested 2 capsules InnoSlim® (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage.

Dietary Supplement: InnoSlim

Placebo

PLACEBO COMPARATOR

Subjects ingested 2 capsules placebo (Control group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage.

Dietary Supplement: Placebo

Interventions

InnoSlimDIETARY_SUPPLEMENT

Subjects ingested 2 capsules (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.

Also known as: Astragalus and Notoginseng extrats
InnoSlim
PlaceboDIETARY_SUPPLEMENT

Subjects ingested 2 capsules placebo in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) ≥ 27 or body fat ≥ 30%;
  • No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
  • No drugs consumption.

You may not qualify if:

  • BMI \>35;
  • Alcoholic;
  • US-controlled diabetics;
  • Stoke in past one year;
  • High blood pressure;
  • Mental diseases or melancholia;
  • Pregency or breast-feeding a child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Chang W.L. et al. The inhibitory effect of ginse¬noside Rg1 on glucose and lipid production in human HepG2 cells. Adaptive Medicine. 2013, 5(4), 181-188.

    RESULT

  • Chang TC, Huang SF, Yang TC, Chan FN, Lin HC, Chang WL. Effect of ginsenosides on glucose uptake in human Caco-2 cells is mediated through altered Na+/glucose cotransporter 1 expression. J Agric Food Chem. 2007 Mar 7;55(5):1993-8. doi: 10.1021/jf062714k. Epub 2007 Feb 2.

    PMID: 17269785RESULT

  • Wang CW, Su SC, Huang SF, Huang YC, Chan FN, Kuo YH, Hung MW, Lin HC, Chang WL, Chang TC. An Essential Role of cAMP Response Element Binding Protein in Ginsenoside Rg1-Mediated Inhibition of Na+/Glucose Cotransporter 1 Gene Expression. Mol Pharmacol. 2015 Dec;88(6):1072-83. doi: 10.1124/mol.114.097352. Epub 2015 Oct 1.

    PMID: 26429938RESULT

MeSH Terms

Conditions

ObesityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • irb@csh.org.tw 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
School of Health Diet and Industry Managment

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

October 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

December 16, 2019

Record last verified: 2019-12