Effects of food set with functional anthocyanin on Changes of Antioxidant activity and Inflammation in volunteers.

Phase 1

Completed

• Conditions: Healthy condition; food set,; functional anthocyanin,; homeostasis,; detoxification,; anti-aging

• Registration Number: TCTR20230811010
• Lead Sponsor: Program Management Unit for National Competitiveness Enhancement (PMU-C)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Study Completion: 2024-01-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Female and male volunteers aged between 20-70 years old with normal healthy.
2. Rough physical fitness assessment with 6 min walk test is within normal criteria.
3. The stress level assessed by the Department of Mental Health's stress assessment form had a score Up to 41 (0-23 low stress, 24-41 moderate stress)
4. Can read and write Thai language

Exclusion Criteria

1. Having serious physical diseases that require continuous medication, including heart disease and vascular disease respiratory disease Nervous system disease, diabetes, hyperlipidemia High blood pressure, kidney disease, liver disease (assessed by AST or ALT 2 times higher than normal, i.e. AST > 64 U/L; ALT > 50 U/L), lung disease or allergies. immune system disease Diseases of the blood system, cancer, diseases of the thyroid gland, adrenal glands, pituitary gland, gout or high uric acid levels. head injury and have a mental disorder or major psychiatric disease
2. In the process of taking lipid-lowering drugs blood sugar lowering drugs blood pressure medication or drugs that interfere with platelet function, such as aspirin and non-steroidal anti-inflammatory drugs
3. Take other dietary supplements that affect the brain, heart and blood vessels, as well as metabolic processes such as weight loss and fat reduction.
4. Consume probiotic foods such as Yakult, yogurt
5. Smoking more than 10 cigarettes per day
6. Drink more than 5 alcoholic beverages per day.
7. In the process of participating in other projects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of detoxification and anti-aging baseline and 5 day HHPHP laboratory

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI), Body Composition, Vital sign,and Respiratoty Rate baseline and 5 day HHPHP laboratory,Electrocardiogram Changes baseline and 5 day HHPHP laboratory,6-minute walk test baseline and 5 day HHPHP laboratory,Stress situation baseline and 5 day Stress questions,Safety parameters Hematology, Blood biochemical markers, Blood electrolytes, Hormones, baseline and 5 day laboratory of hospital,Changes of Homocysteine, Insulin, and Cortisol baseline and 5 day HHPHP laboratory,Changes of Inflammatory markers IL-6 baseline and 5 day HHPHP laboratory,Changes of Monoamine oxidase, and Acetylcholinesterase baseline and 5 day HHPHP laboratory,Changes of Malondialdehyde (MDA), 8-OHDG , and Nrf2 baseline and 5 day HHPHP laboratory,Changes of Telomerase, CYP3A4, DNA methyltransferase 1 (DNMT1), Histone deacetylase, and Histone acetylase baseline and 5 day HHPHP laboratory,Changes of Lactobacillus spp. and Bifidobacterium spp baseline and 5 day HHPHP laboratory