Human study of Theracurmin for verification of anti-oxidant effect

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0008731
• Lead Sponsor: Seoul National University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-03
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Healthy adult males and females between the ages of 30 and 59 years.
2) The people who agree to participate in this human clinical trial and complete a written informed consent form before the start of the human clinical trial.

Exclusion Criteria

1) Have or are currently being treated for a serious cardiovascular, immune, respiratory, gastrointestinal/liver and biliary, renal and urinary, neurologic, musculoskeletal, psychiatric, or infectious disease
2) Diagnosed with thyroid disease diabetes and currently taking related medications
3) Have had a surgical procedure within 6 months of Visit 1
4) Unable to perform treadmill exercise
5) Maximal oxygen uptake (VO2 max) in the exercise is greater than or equal to grade 1 for their age group
6) Continued regular exercise within 3 months prior to Visit 1 (3 or more days per week, 30 minutes or more of exertion per day).
7) BMI less than or equal to 18 kg/m2 and greater than or equal to 30 kg/m2
8) Those who score 47.7 or more in the balance category and 67.3 or more in the variety category on the Nutrition Index Questionnaire.
9) Excessive alcohol consumers (420 g/week or more: about 7 bottles/week, 1 bottle/day based on soju) or alcoholics
10) Smokers, Drug addicts (However, those who have quit smoking for more than 1 year as of Visit 1 are eligible to participate.
11) Subjects who have taken nutritional supplements (vitamins, amino acids, creatine, protein drinks, etc.) within 2 months prior to Visit 1.
12) Use of dietary supplements (red ginseng, chlorella, green tea extract, spirulina, propolis extract, coenzyme Q10, squalene, tomato extract, etc.) or medications (lipid-lowering, anti-inflammatory, blood pressure-lowering, antibiotics, aspirin, anti-inflammatory, blood glucose-lowering, anticoagulants, steroids, etc.) and chinese medicine
13) Subjects with uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 100 mmHg, measured after 10 minutes of subject rest)
14) Subjects who have lost more than 4 kg of body weight within 1 month of Visit 1
15) Pregnant or lactating women or those planning to become pregnant during the course of this human study
16) Participation in another interventional clinical trial (including human clinical trials) within 3 months of Visit 1, or plans to participate in another interventional clinical trial (including human clinical trials) after the start of this human clinical trial.
17) Subjects who are sensitive or allergic to any of the food ingredients in this human clinical trial.
18) Subjects deemed unsuitable by the investigator for any other reason.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy (CAT activity, TOS&TAS etc.)

Secondary Outcome Measures

Name	Time	Method
Safety (Checking for adverse effects, Hemoglobin, AST (GOT), ALT(GPT), Blood pressure, Pulse etc.)