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

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

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

Study Overview

• Status: Completed
• Conditions: Hyperglycemia
• Intervention / Treatment: Dietary supplement: Angelica gigas N. extract; Dietary supplement: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Placebo for 8 weeks	Dietary supplement: Placebo; Placebo for 8 weeks
EXPERIMENTAL: Angelica gigas N. extract; capsules(2cap/d, 1,000mg/d) for 8 weeks.	Dietary supplement: Angelica gigas N. extract; capsules(2cap/d, 1,000mg/d) for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of blood insulin during OGTT	Changes of blood insulin during OGTT were assessed before and after the intervention.	8 weeks
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
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
Changes of HbA1c	Changes of HbA1c(%) were assessed before and after the intervention	8 weeks
Changes of Adiponectin, Leptin	Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention	8 weeks
Changes of lipid profile	Changes of lipid profile were assessed before and after the intervention	8 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2017
• Primary Completion (ACTUAL): December 7, 2017
• Study Completion (ACTUAL): December 7, 2017

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Clinical Trial; Glucose; Angelica gigas N. extract
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: WBP-HG-AG2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No