Effect of tuna-derived protein hydrolysate on endothelial dysfunction of overweight and obesity

Phase 1

Recruiting

• Conditions: Healthy condition; Tuna; Protein hydrolysate; Endothelial dysfunction; Overweight; Obesity

• Registration Number: TCTR20230621002
• Lead Sponsor: Program Management Unit Competitiveness (PMUC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Last Update Posted: 19 August 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Both male and female subjects aged between 45-65 years old and normal healthy subjects.
2. Overweight: Body mass index (BMI) more 25 kg/m2
3. The female subjects had normal menstrual cycles.
4. Females have a waist circumference of 80 centimeters or 32 inches or more.
5. Males have a waist circumference of 90 centimeters or 36 inches or more.
6. The blood pressure value is not more than 130 per 85 mm Hg.
7. Sugar and fat levels are within normal limits. (8 hours after fasting sugar level less than 100 mg/dL and triglyceride level (Triglycerides) less than 150 mg/dL)
8. Can read and write Thai language

Exclusion Criteria

1. Have severe underlying diseases that require continuous medication, including cardiovascular disease, respiratory disease, Nervous system disease, diabetes, hyperlipidemia, High blood pressure, kidney disease, liver disease (assessed by AST or ALT is 2 times higher than normal (AST > 64 U/L; ALT > 50 U/L), lung disease or allergy, immune system disease, Hematologic disease, cancer, gout or high uric acid levels.
2. Have received drugs or hormones or other types of herbal medicines that affect the nervous system in the past 3 months before participating in the project.
3. Have to take any medication that affects the functioning of the nervous system as instructed by the treating physician prior to joining the project
4. Alcohol drinking more than 5 glasses per day.
5. Smoking more than 10 cigarettes per day
6. Subjects did not follow instructions during the experiment.
7. In the process of participating in other projects
8. Pregnant or planned to become pregnant at the time of the study.
9. Breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial dysfunction basline, 6 week, 12 week flow mediated dilatation

Secondary Outcome Measures

Name	Time	Method
Safety parameters (Hematology, Blood biochemical markers and Blood electrolytes) basline, 6 week, 12 week Hospital laboratory,Changes of nitrate, nitrite, NO, cTnT, cTnI, AII, endothelin, and Atherogenic index of plasma (AIP) basline, 6 week, 12 week HHPHP laboratory,Changes of Inflammatory markers levels; hs-CRP, Interleukin-6 (IL-6) and TNF-alpha basline, 6 week, 12 week HHPHP laboratory,Changes of Electrocardiogram and Heart rate variability basline, 6 week, 12 week Holter monitor,Body Mass Index (BMI), Body Composition, and Anthropometry basline, 6 week, 12 week HHPHP laboratory,Autonomic nervous system assessment basline, 6 week, 12 week Holter monitor