Healthy condition Safety Cashew leaf Functional drink Changes of sleep Working age volunteers
Conditions
Interventions
Subjects receive the placebo jelly drink which has the same color, taste and looks like the functional jelly drink.,Subjects receive the functional jelly drink containing 10 mg of the cashew derived
Placebo,Jelly drink containing 10 mg of the cashew derived functional ingredient.,Jelly drink containing 100 mg of the cashew derived functional ingredient.
Sponsors
Agricultural Research Development Agency (Public Organization)
Eligibility
Sex/Gender
All
Age
35 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Both male and female volunteers between 35 - 60 ages who were normal health. 2. The female subjects had normal menstrual cycles, must have expired and not receiving hormones 3. Can read and write Thai language
Exclusion criteria
Exclusion criteria: 1. Have been diagnosed with lung disease, asthma or allergies, cardiovascular disease. respiratory disease Neuropathy or head injury Gout or high uric acid, diabetes, high blood lipids High blood pressure, kidney disease, liver disease (assessed by AST or ALT values 2 times higher than normal, i.e. AST > 64 U/L; ALT > 50 U/L), cancer, immune system diseases. blood system disease and have been diagnosed with a psychiatric disorder, including Anxiety Disorder or Depression or Schizophrenia or Attention Deficit Hyperactivity Disorder or Autism or Learning Disorder. 2. Have a history of substance abuse 3. Use any medication/supplement that affects the functioning of the nervous system as instructed by the treating physician before joining the project 4. Eat fermented foods or yoghurt or probiotics more than 3 times a week. 5. Moderate strenuous exercise 3 or more days per week. 6. Use any drugs or other types of herbal medicine at least 1 month before joining the project. 7. Being pregnant or planning to become pregnant during the study 8. Breastfeeding. 9. In the process of participating in other projects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Quality of sleep Baseline, Day1, Day7, Day28 Questionnaires of Pittsburgh Sleep Quality Index (PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of State Worrying Baseline, Day1, Day7, Day28 State Worrying Questionnaire (PSWQ),Changes of Anxiety Baseline, Day1, Day7, Day28 Beck Anxiety Inventory (BAI),Changes of negative/postive Mood Baseline, Day1, Day7, Day28 MOSAIC Questionnaire, Safety parameters Hematology, Blood biochemical markers, Blood electrolytes, Hormones, Baseline, Day28 laboratory of hospital,Working memory test Baseline, Day7, Day28 Computerized batteries test (CDR),Working memory test Baseline, Day7, Day28 Event Related Potentials (ERPs),Body Mass Index (BMI), Body Composition and Anthropometry Baseline, Day1, Day7, Day28 laboratory of HHPHP,Electrocardiogram Baseline, Day1, Day7, Day28 laboratory of HHPHP,Changes of acetylcholinesterase (AChE), monoamine oxidase (MAO; total MAO, MAOA, MAOB, GABA transaminase ) Baseline, Day1, Day7, Day28 laboratory of HHPHP,Changes of Brain Derived Nerve Growth Factor (BDNF), and TNF-alpha Baseline, Day7, Day28 laboratory of HHPHP,No. of Lactobacillus spp., Bifidobacterium spp. in fecal sample Baseline, Day28 laboratory of HHPHP | — |
Countries
Thailand
Contacts
Public ContactPongsatorn Paholpak
Faculty of Medicine, Khon Kaen University
Outcome results
None listed