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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230621002
Enrollment
120
Registered
2023-06-21
Start date
2023-08-29
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

Healthy condition Tuna Protein hydrolysate Endothelial dysfunction Overweight Obesity

Interventions

Subjects receive the placebo capsule which has the same color and looks like the functional capsule.,Subjects receive the functional capsule containing 1 g Tuna-derived protein hydrolysate/day.,Subje
Placebo,Capsule containing 1 g Tuna-derived protein hydrolysate,Capsule containing 3 g Tuna-derived protein hydrolysate

Sponsors

Program Management Unit Competitiveness (PMUC)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Endothelial dysfunction basline, 6 week, 12 week flow mediated dilatation

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactJintanaporn Wattanathorn

Faculty of Medicine, Khon Kaen University

jinwat@kku.ac.th66818721809

Outcome results

None listed

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