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Study of Obesity Control by Astragalus and Notoginseng Extrats

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ClinicalTrials.gov Identifier: NCT03654391
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
You-Cheng Shen, Chung Shan Medical University

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study of Obesity Control by Astragalus and Notoginseng Extrats
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017

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 Name: 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.




Primary Outcome Measures :
  1. The changes of body weight and BMI of the subjects. [ Time Frame: 12 weeks ]
    values change of body weight and BMI between before to after 12 weeks


Secondary Outcome Measures :
  1. The changes of triglyceride (TG) of the subjects [ Time Frame: 12 weeks ]
    values change of triglyceride (TG) between before to after 12 weeks



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03654391


Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: irb@csh.org.tw Mr Shen, Ph.D. Chung Shan Medical University
Publications of Results:
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Responsible Party: You-Cheng Shen, School of Health Diet and Industry Managment, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03654391    
Other Study ID Numbers: CS16098
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Keywords provided by You-Cheng Shen, Chung Shan Medical University:
Astragalus and Notoginseng extrats
Body weight
BMI
Triglyceride
obese
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight