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

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Angelica gigas N. extract
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Angelica gigas N. extract, Glucose, Clinical Trial

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Angelica gigas N. extract

Placebo

Arm Description

capsules(2cap/d, 1,000mg/d) for 8 weeks.

Placebo for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes of blood insulin during OGTT
Changes of blood insulin during OGTT were assessed before and after the intervention.
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
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
Changes of HbA1c
Changes of HbA1c(%) were assessed before and after the intervention
Changes of Adiponectin, Leptin
Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention
Changes of lipid profile
Changes of lipid profile were assessed before and after the intervention

Full Information

First Posted
March 9, 2017
Last Updated
August 21, 2019
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03258229
Brief Title
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Angelica gigas N. extract, Glucose, Clinical Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
2×2 cross-over Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angelica gigas N. extract
Arm Type
Experimental
Arm Description
capsules(2cap/d, 1,000mg/d) for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Angelica gigas N. extract
Intervention Description
capsules(2cap/d, 1,000mg/d) for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 8 weeks
Primary Outcome Measure Information:
Title
Changes of blood glucose during OGTT (oral glucose tolerance test)
Description
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes of blood insulin during OGTT
Description
Changes of blood insulin during OGTT were assessed before and after the intervention.
Time Frame
8 weeks
Title
Changes of Homeostatic model assessment-insulin resistance
Description
Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention
Time Frame
8 weeks
Title
Changes of Homeostatic model assessment-beta-cell
Description
Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
Time Frame
8 weeks
Title
Changes of HbA1c
Description
Changes of HbA1c(%) were assessed before and after the intervention
Time Frame
8 weeks
Title
Changes of Adiponectin, Leptin
Description
Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention
Time Frame
8 weeks
Title
Changes of lipid profile
Description
Changes of lipid profile were assessed before and after the intervention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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