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Evaluation of safety and effect of consumption of jelly drink with the cashew derived functional ingredient on changes of sleep in working age volunteers

Phase 1
Active, not recruiting
Conditions
Healthy condition
Safety
Cashew leaf
Functional drink
Changes of sleep
Working age volunteers
Registration Number
TCTR20230711007
Lead Sponsor
Agricultural Research Development Agency (Public Organization)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
93
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes of Quality of sleep Baseline, Day1, Day7, Day28 Questionnaires of Pittsburgh Sleep Quality Index (PSQI)
Secondary Outcome Measures
NameTimeMethod
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