Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia

Hyperglycemia Clinical Trial

Official title:

A 8-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258229
• Other study ID #: WBP-HG-AG2
• Status: Completed
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: December 7, 2017

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Hyperglycemia .

Description:

This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl

Exclusion Criteria:

• Weight less than 48 kg or weight decreased by more than 10% within past 3 months

• Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks

• Treated with corticosteroid within past 4 weeks

• Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)

• Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)

• Rheumatoid arthritis, Autoimmune disease

• Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)

• Allergic or hypersensitive to any of the ingredients in the test products

• History of disease that could interfere with the test products or impede their absorption

• Under antipsychotic drugs therapy within past 2 months

• History of alcohol or substance abuse

• Participation in any other clinical trials within past 2 months

• Laboratory test by show the following results

• aspartate aminotransferase, alanine aminotransferase > Reference range upper limit treble

• Serum Creatinine > 2.0 mg/dl

• Pregnancy or breast feeding

• Not Contraception(except: Surgery for female infertility)

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Dietary Supplement:
• Angelica gigas N. extract
capsules(2cap/d, 1,000mg/d) for 8 weeks.
• Placebo
Placebo for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of blood glucose during OGTT (oral glucose tolerance test)	Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.	8 weeks
Secondary	Changes of blood insulin during OGTT	Changes of blood insulin during OGTT were assessed before and after the intervention.	8 weeks
Secondary	Changes of Homeostatic model assessment-insulin resistance	Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention	8 weeks
Secondary	Changes of Homeostatic model assessment-beta-cell	Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention	8 weeks
Secondary	Changes of HbA1c	Changes of HbA1c(%) were assessed before and after the intervention	8 weeks
Secondary	Changes of Adiponectin, Leptin	Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention	8 weeks
Secondary	Changes of lipid profile	Changes of lipid profile were assessed before and after the intervention	8 weeks