Effects of dietary supplement contained anthocyanin from black rice, inulin and fiber on oxidative stress, inflammation, insulin resistance, fat oxidation and cardiovascular function in type 2 diabetes mellitus patients

Not Applicable

• Conditions: Fat Oxidation; Diabetes Mellitus; Anthocyanins; Inulin; Dietary Fiber; Oxidative Stress; Inflammation; Insulin Resistance; Cardiovascular Function

• Registration Number: TCTR20190804003
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-04
• Study Completion: 2020-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Subjects are male and female patients aged 30-60 years who are diagnosed with type 2 diabetes mellitus (T2DM) longer than 1 year.
2. Subjects who sign the consent form and can participate in the study until the end of project.

Exclusion Criteria

1. Subjects with liver, kidney and thyroid diseases.
2. Subjects with respiratory tract diseases including asthma and chronic obstructive pulmonary disease (COPD).
3. Subjects with cardiovascular disease including heart failure and coronary artery disease (CAD).
4. Subjects with symptoms associated with neuromuscular disorders such as dizziness, nausea, vomiting, osteoporosis, muscle weakness and spinal stenosis.
5. Subjects with chronic infection.
6. Subjects who regularly drink alcohol or smoking.
7. Subjects who take hormones or nutritional supplements regularly.
8. Subjects who were reported that allergy to the ingredients of dietary supplements used in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malondialdehyde (MDA) Concentration (Oxidative Stress) 1 day Colorimetry based method,Vitamin C Level (Oxidative Stress) 1 day Colorimetry based method

Secondary Outcome Measures

Name	Time	Method
Interleukin (IL)-6 Level (Inflammation) 1 day Assay Kit,Insulin Resistance 1 day HOMA-IR will be Used to Assess Insulin Resistance, and will be Calculated by the Formula ,Fat Oxidation Rate 1 day Using Gas Analyzer and Calculate Fat Oxidation Rate by Using the Equation,Maximal Oxygen Consumption (VO2max) (Cardiovascular Function) 1 day 6 Minutes Walk Test (6MWT) with Moderate Intensity,Blood Vessel Thickness (Cardiovascular Function) 1 day Skin Ultrasound Examination,Heart Rate Variability (HRV) Assessment (Cardiovascular Function) 1 day Using SA-3000P HRV analyzer