A Study on the Improvement Effect of extract of Aster sphathulifolius Maxim on Human Application

Double blind, randomized controlled study to evaluate the efficacy and safety of extract of Aster sphathulifolius Maxim on the glucose metabolism.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005917

Enrollment

Registered

2021-02-19

Start date

2015-10-01

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The ratio of 1: 1 to extract of Aster sphathulifolius Maxim group and placebo group is randomly assigned to each group, and to take extract of Aster sphathulifolius Maxim or place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) obese (BMI: 25-30 kg/m2), non-diabetic (fasting glucose < 126 mg/dL and HbA1c < 6.5%), and aged 21~65, (2) who do not have a treatment history of anti-obesity and/or anti-diabetic medication within 3 months (3) who informed and voluntarily consented to participate to the study.

Exclusion criteria

Exclusion criteria: 1)fasting glucose > 126 mg/ml or HbA1c > 6.5%; 2)subjects who had taken anti-diabetic medication and/or glucocorticoids within 3 months; 3)had serious illness history, including depression, heart disease, and cancer; drug or alcohol abusers; 4)had hepatic disease with AST or ALT > 3-fold than normal range; had kidney abnormality with creatinine level > 1.5mg/dL; individuals who need treatment for hyperthyroidism or hypothyroidism. 5) Those who have been taking glucocorticoids that may affect blood sugar within the last 3 months 6) Drug abusers or people with history (including alcohol) 7) Patients with a history of severe disease that may recur during or immediately after the clinical trial 8) individuals who need treatment for hyperthyroidism or hypothyroidism (However, hypothyroidism that does not require treatment with TSH less than 10 µg/dl is not applicable) 9) Others who are judged to be unable to participate in clinical research

Design outcomes

Primary

Measure	Time frame
Changes in Fasting glucose, Insulin, c-peptide after 12 weeks compared to baseline;Changes in HOMA-IR, HOMA-beta after 12 weeks compared to baseline	—

Secondary

Measure	Time frame
Changes in glycoalbumin, Weight, body fat, waist circumference, Total cholesterol, Triglyceride, LDL-C, HDL-C after 12 weeks compared to baseline;Changes in HbA1C after 12 weeks compared to baseline	—

Countries

Korea, Republic of

Contacts

Public ContactJung-hwa lee

Kyung Hee University Hospital at Gangdong

Outcome results