Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential

NCT03268447 | Completed

• 1 other identifier: USM/JEPeM/16050195
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health properties, primarily alleviation of stress, among adults in Malaysia aged from 18 to 60 years.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale (PSS) Scores

  Stress Questionnaires for the determination of stress (low, moderate, high)

  12 weeks

Secondary Outcomes (1)

• Fecal microbiota profiling

  12 weeks

Study Arms (2)

Lactobacillus plantarum P8

ACTIVE COMPARATOR

Intervention consists of daily administration of 2g probiotic Lactobacillus plantarum P8, administered daily at a fixed dosage of 10 log CFU/sachet/day and continue for 12 weeks.

Dietary Supplement: Lactobacillus plantarum P8

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 weeks.

Dietary Supplement: Placebo

Interventions

Lactobacillus plantarum P8 DIETARY_SUPPLEMENT

This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.

Also known as: P8

Lactobacillus plantarum P8

Placebo DIETARY_SUPPLEMENT

This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects
• years old
• No severe illness
• BMI within a healthy range
• Score between 13 -20 (moderate stress level) on Cohen's Perceived Stress Scale (PSS)
• Willing to commit throughout the experiment

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Beijing Scitop Bio-Tech Shareholding Co.Ltd.: collaborator

Study Sites (1)

School of Industrial Technology

Universiti Sains Malaysia, Pulau Pinang, 11900, Malaysia

Location

Related Publications (3)

• Kwok LY, Guo Z, Zhang J, Wang L, Qiao J, Hou Q, Zheng Y, Zhang H. The impact of oral consumption of Lactobacillus plantarum P-8 on faecal bacteria revealed by pyrosequencing. Benef Microbes. 2015;6(4):405-13. doi: 10.3920/BM2014.0063. Epub 2015 Feb 12.

  PMID: 25653153 BACKGROUND

• Wang L, Zhang J, Guo Z, Kwok L, Ma C, Zhang W, Lv Q, Huang W, Zhang H. Effect of oral consumption of probiotic Lactobacillus planatarum P-8 on fecal microbiota, SIgA, SCFAs, and TBAs of adults of different ages. Nutrition. 2014 Jul-Aug;30(7-8):776-83.e1. doi: 10.1016/j.nut.2013.11.018. Epub 2013 Dec 4.

  PMID: 24984992 BACKGROUND

• Lew LC, Hor YY, Yusoff NAA, Choi SB, Yusoff MSB, Roslan NS, Ahmad A, Mohammad JAM, Abdullah MFIL, Zakaria N, Wahid N, Sun Z, Kwok LY, Zhang H, Liong MT. Probiotic Lactobacillus plantarum P8 alleviated stress and anxiety while enhancing memory and cognition in stressed adults: A randomised, double-blind, placebo-controlled study. Clin Nutr. 2019 Oct;38(5):2053-2064. doi: 10.1016/j.clnu.2018.09.010. Epub 2018 Sep 19.

  PMID: 30266270 DERIVED

Study Officials

• Min Tze Liong, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: Placebo and P8 will be administered via a parallel design

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 31, 2017
• Study Start: August 5, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)