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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190804003
Enrollment
Unknown
Registered
2019-08-04
Start date
2019-10-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Diabetes Mellitus Diabetes Mellitus Anthocyanins Inulin Dietary Fiber Oxidative Stress Inflammation Insulin Resistance Fat Oxidation Cardiovascular Function

Interventions

Dietary Supplement Containing a Mixtures of Anthocyanins&#44
Inulin and Fiber Capsule as Intervention Group,Maltodextrin Powder will be Contained into Each Capsule for Using as Placebo
Experimental Dietary Supplement,Placebo Comparator No treatment
Anthocyanins&#44
Inulin and Fiber Capsule ,Placebo Capsule

Sponsors

National Research Council of Thailand
Lead Sponsor
Exercise and Sport Sciences Development and Research Group&#44
Collaborator
Khon Kaen University
Collaborator

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Malondialdehyde (MDA) Concentration (Oxidative Stress) 1 day Colorimetry based method,Vitamin C Level (Oxidative Stress) 1 day Colorimetry based method

Secondary

MeasureTime frame
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

Contacts

Public ContactChompoonut Teparak

Graduate School, Khon Kaen University

chompoonut27@gmail.com082-566-9917

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026