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

NCT03258229 | Completed DMC

• 1 other identifier: WBP-HG-AG2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperglycemia

Keywords

Angelica gigas N. extract; Glucose; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes of blood insulin during OGTT

  8 weeks

• Changes of Homeostatic model assessment-insulin resistance

  8 weeks

• Changes of Homeostatic model assessment-beta-cell

  8 weeks

• Changes of HbA1c

  8 weeks

• Changes of Adiponectin, Leptin

  8 weeks

Study Arms (2)

Angelica gigas N. extract

EXPERIMENTAL

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

Dietary Supplement: Angelica gigas N. extract

Placebo

PLACEBO COMPARATOR

Placebo for 8 weeks

Dietary Supplement: Placebo

Interventions

Angelica gigas N. extract DIETARY_SUPPLEMENT

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

Angelica gigas N. extract

Placebo DIETARY_SUPPLEMENT

Placebo for 8 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Model Details: 2×2 cross-over Assignment

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: August 23, 2017
• Study Start: February 9, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

KR (1)