Stress Clinical Trial
— DR7Official title:
Lactobacillus Plantarum DR7 for Gut-Brain-Axis Benefits
Verified date | July 2018 |
Source | University of Science Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health properties, primarily alleviation of stress, among adults in Malaysia aged from 18 to 60 years.
Status | Completed |
Enrollment | 118 |
Est. completion date | March 31, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male or female subjects - 18-60 years old - Willing to commit throughout the experiment - Have moderate stress and beyond, as per determined by PSS test Exclusion Criteria: - Type-1 diabetes (one of the main metabolite of Lactobacillus is acetic acid. Acetic acid has been reported to affect lipid metabolism in the liver and fat digestion in the pancreas in animal studies, and has been applied in obesity studies) - Long term medication due to certain severe illness (certain medications may interfere with the survivability of Lactobacillus in the gut, for example the interactions between probiotics and warfarin - HIV/AIDS (there has been no substantial data on the detrimental effects of probiotics on AIDS patients. However, AIDS patient may be immune-compromised in the sense of "leaky gut" that may lead to bacterial translocation, including translocation of Lactobacillus outside the gut environment, into the blood stream) - Glucose-6-phosphate dehydrogenase (G6PD) deficiency (there has been no substantial data on the detrimental effects of probiotics on G6PD deficiency people. However, certain strains of probiotics have been reported to benefit RBC irregularity disorders such as spur cells formation. One of the main mechanisms, involve the alteration of RBC membrane. Although this is a benefit, we are unsure of the effects on G6PD deficiency people, with weaker RBC). |
Country | Name | City | State |
---|---|---|---|
Malaysia | School of Industrial Technology, Universiti Sains Malaysia | Pulau Pinang | Penang |
Lead Sponsor | Collaborator |
---|---|
University of Science Malaysia | Clinical Nutrition Sdn Bhd |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alleviation of stress | To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in alleviation of stress using PSS questionnaire | 12 weeks | |
Primary | Alleviation of depression | To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in alleviation of depression using DASS42 questionnaire | 12 weeks | |
Primary | Enhancement of cognition ability | To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in enhancing cognition ability using Cogstate Brief Battery | 12 weeks | |
Secondary | Alleviation of respiratory tract infections | To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in reducing upper respiratory episodes and symptoms using illness symptom chart | 12 weeks | |
Secondary | Alleviation of gastrointestinal disorders | To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in reducing diarrhea incidents using illness symptom chart | 12 weeks | |
Secondary | Enhancement of immunity | To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in enhancing immunity via blood cytokines analyses | 12 weeks |
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