Study of Obesity Control by Astragalus and Notoginseng Extrats

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: InnoSlim; Dietary supplement: Placebo

Detailed Description

Obesity refers to the body due to physiological or biochemical function of the change caused by excessive accumulation of body fat, resulting in weight gain. Hence, the aim of this study was to evaluate the effects of the Astragalus and Notoginseng extrats on obesity control by a randomized double-blind and crossover human trial. Subjects with simple obesity (body mass index (BMI) ≥ 27 or body fat ≥ 30%) ingested 5 extrats (n = 19) capsules or placebo (n = 19) perday for 12 weeks of a stage. Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every six weeks.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: InnoSlim; 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; 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.; Other Names: Astragalus and Notoginseng extrats
Placebo Comparator: Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of triglyceride (TG) of the subjects	values change of triglyceride (TG) between before to after 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Principal Investigator: irb@csh.org.tw Mr Shen, Ph.D., Chung Shan Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: BMI; Body weight; obese; Astragalus and Notoginseng extrats; Triglyceride
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: CS16098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No