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Completed

NCT Number: NCT03258229

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 .

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Angelica gigas N. extract

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo for 8 weeks

Primary outcomes

  1. Changes of blood glucose during OGTT (oral glucose tolerance test)

    Time frame: 8 weeks

    Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.

Secondary outcomes

  1. Changes of blood insulin during OGTT

    Time frame: 8 weeks

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

  2. Changes of Homeostatic model assessment-insulin resistance

    Time frame: 8 weeks

    Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention

  3. Changes of Homeostatic model assessment-beta-cell

    Time frame: 8 weeks

    Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention

  4. Changes of HbA1c

    Time frame: 8 weeks

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

  5. Changes of Adiponectin, Leptin

    Time frame: 8 weeks

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

  6. Changes of lipid profile

    Time frame: 8 weeks

    Changes of lipid profile were assessed before and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2017
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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