Epigenetic age Quality of life Cognitive function Inflammatory biomarker Essence of chicken epigenetic age quality of life cognitive inflammatory biomarker
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to sign written informed consent 2. Willing to consume Essence of Chicken or placebo and follow the study procedure 3. A healthy subject aged 35 to 45 years. The term healthy is defined as no underlying disease, no clinically significant abnormality identified by detailed medical history, physical examination, including blood pressure and clinical laboratory tests. 4. Must not participate in other clinical studies.
Exclusion criteria
Exclusion criteria: 1. Has a history of allergy to Essence of Chicken or any ingredients of Investigational product (IP) 2. Has an evidence or history of clinically significant diseases, including but not limited to malignancies, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, autoimmune and allergic diseases, active infections or clinical findings at screening based on interview, medical history, blood test, vital signs and physical examination. Untreated, asymptomatic seasonal allergies at the time of screening can be included. 3. Body Mass Index > 30 kg/m2 4. Any laboratory test or clinical signs and symptoms greater than grade 1 of NCI CTCAE grading. Unless the value can be seen as isolated and may be temporarily elevated and not lead to any chronic disease. 5. Has clinically significant abnormalities in laboratory test results under investigator judgement. 6. Has other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 7. Concurrent pharmacological treatments (with the exception of regular contraceptive pills, eye drops, and topical medicines) or use of cannabis-containing products. 8. Any recent drastic changes in lifestyle, including diet (e.g., beginning a vegetarian diet or low-calorie diet, drastic changes in alcohol or caffeine consumption pattern), exercise level, smoking pattern, sleep habits and supplement intake patterns in the last 4 weeks. 9. Judgment by the investigator that the subject should not participate in the study, for instance if the subject is unlikely to comply with all study procedures (e.g. maintaining the same lifestyle throughout the study period from screening to end of the study) or if subject is unlikely to be in good health throughout the study. 10. Regular consumption of any Essence of Chicken, defined as > 2 times a week of consumption in the past 6 months. 11. Heavy smokers consuming 7 or more standard packs per week. (1 standard pack = 20 cigarettes) 12. Heavy drinkers consuming 15 or more standard drinks per week. 13. Individuals with poor sleep habits. (i.e. allocate less than 4 hours of sleep per night) 14. Women who are pregnant or lactating or has a plan to become pregnant during study period. 15. Current enrolment in another interventional study or refusal to refrain from participating in another interventional study during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DunedinPACE (Epigenetic age) Baseline, 12 months TruDiagnostic kit | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Baseline, 6 month, 12 month RAND-36 Questionnaire ,Cognitive Function Baseline, 6 month, 12 month PROMIS Cognitive Function - Abilities - Short Form 8a Questionnaires,Biological Age (GrimAge, PhenoAge, etc) Baseline, 12 month TruDiagnostic kit,Long-term consumption of BEC Baseline, 12 month Changes of the safety parameters (Blood test) | — |
Countries
Thailand
Contacts
Faculty of Pharmacy, Mahidol University