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CompletedNCT03258229Updated Aug 22, 2019

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

An interventional study of Angelica gigas N. extract and Placebo in Hyperglycemia, sponsored by Chonbuk National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-22.

Sponsored by Chonbuk National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hyperglycemia

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Keywords

  • Angelica gigas N. extract
  • Glucose
  • Clinical Trial
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Angelica gigas N. extract

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

    Dietary Supplement: Angelica gigas N. extract

  • Placebo comparator
    Placebo

    Placebo for 8 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAngelica gigas N. extract

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

  • Dietary supplementPlacebo

    Placebo for 8 weeks

05

What researchers measure

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.

    Time frame: 8 weeks

Secondary outcomes

  1. Changes of blood insulin during OGTT

    Changes of blood insulin during OGTT were assessed before and after the intervention.

    Time frame: 8 weeks

  2. 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

    Time frame: 8 weeks

  3. 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

    Time frame: 8 weeks

  4. Changes of HbA1c

    Changes of HbA1c(%) were assessed before and after the intervention

    Time frame: 8 weeks

  5. Changes of Adiponectin, Leptin

    Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention

    Time frame: 8 weeks

  6. Changes of lipid profile

    Changes of lipid profile were assessed before and after the intervention

    Time frame: 8 weeks

06

Study locations

1 site
  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 560-822, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03258229
Lead sponsor
Chonbuk National University Hospital
Responsible party
Soo-Wan Chae (Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital) — Principal investigator
First posted
Aug 23, 2017
Start date
Feb 9, 2017
Primary completion
Dec 7, 2017
Completion
Dec 7, 2017
Last update
Aug 22, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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