The Cognitive Effects of 6 Weeks Administration With a Probiotic

The Cognitive Effects of 6 Weeks Administration With a Probiotic: a Randomized, Placebo Controlled Proof-of-concept Study in Healthy Elderly Humans

The purpose of this study is to investigate the cognitive and mood effects of a probiotic dietary supplement when taken daily for 42 days in healthy older adults aged 65+

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: Lactobacillus paracasei Lpc-37; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
      • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, aged ≥ 65 years
2. Willing and able to provide written and informed consent
3. Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
4. Agreement to comply with the protocol and study restrictions
5. Available for all study visits
6. In good general health, self-reported and as judged by the Principal Investigator/Clinical advisor based on medical history
7. Fluent in written and spoken English
8. Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period
9. Has a bank account (required for payment)

Exclusion criteria:

1. Have any pre-existing significant acute or chronic co-existing medical condition / illness which contraindicates, in the Principal Investigator's judgement, entry to the study NOTE: the explicit exceptions to this are controlled (medicated) hypertension, arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progess to screening if they have a condition/illness which would not interact with the active treatments or impede performance
2. History of dementia, stroke and other neurological conditions
3. Traumatic loss of consciousness in the last 12 months
4. History of epilepsy or Parkinson's disease
5. Anxiety, depression or any psychiatric disorder that the Principal Investigator believes would interfere with the objectives of the study and requiring treatment in the last 2 years
6. Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) prescription medications that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results such as psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers) NOTE: the explicit exceptions to this are hormone replacement treatments for female participants where symptoms are stable, those medications used in the treatment of arthritis, high blood pressure, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening
7. Currently taking (from day of screening onwards) medication or dietary supplements that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results such as: melatonin, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St. John's Wort or other cognitive enhancing dietary or herbal supplements over the study period
8. Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
9. Daily consumption of concentrated sources of probiotics and / or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic / prebiotic tablets, capsules, drops or powders), including yoghurt or yoghurt drinks
10. Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
11. Have a Body Mass Index (BMI) outside of the range 18.5-29.9 kg/m2
12. Have learning difficulties, dyslexia
13. Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
14. Current smoker (use of nicotine replacement products, vaping, gum, patches etc)
15. Have a history of alcohol or drug abuse
16. Current misuse of alcohol, drug or prescription medications
17. Excessive caffeine intake (>500 mg per day)
18. Excessive alcohol consumption (drinking on 5 or more days a week or consuming > 6 units of alcohol in a single session on 5 or more days a week) for 3 weeks prior to screening and during the intervention period
19. Contraindication to any substance in the investigational product
20. Principal Investigator believes that the participant may be uncooperative and / or noncompliant and should therefore not participate in the study
21. Participant under legal or administrative supervision
22. Have food intolerances / sensitivities
23. Have any health condition that would prevent fulfilment of the study requirements
24. Are unable or unwilling to complete all the study assessments
25. Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lactobacillus paracasei Lpc-37; Probiotic	Dietary supplement: Lactobacillus paracasei Lpc-37; Live probiotic bacteria
PLACEBO_COMPARATOR: Placebo; Inert placebo	Dietary supplement: Placebo; Inert placebo matched for taste and appearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodic memory score	This is a composite measure derived from summing the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition (-4 to 4)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI-state total score	State-trait anxiety inventory 'state' total score (20-80)	6 weeks
STAI-trait total score	State-trait anxiety inventory 'trait' total score (20-80)	6 weeks
Accuracy of attention score	This is a composite measure derived from summing the z score accuracy performance on the choice reaction time and Rapid visual information processing tasks (-2 to 2)	6 weeks
Speed of attention score	This is a composite measure derived from summing the z score reaction times from the choice reaction time and Rapid visual information processing task (-2 to 2)	6 weeks
Working memory score	This is a composite measure derived from summing the z score accuracy performance on the numeric working memory task and Corsi block-tapping task (-2 to 2)	6 weeks
Speed of memory score	This is a composite measure derived from summing the z score reaction times on the numeric working memory task, the delayed name / face recall task, the delayed picture recognition task and the delayed word recognition task (-4 to 4)	6 weeks
Delayed word recall correct	total number of correctly identified words (0-15)	6 weeks
Delayed word recall errors	total number of error responses	6 weeks
Picture recognition reaction time	(ms)	6 weeks
Picture recognition accuracy		6 weeks
Word recognition reaction time	(ms)	6 weeks
Word recognition accuracy		6 weeks
Name to Face Recall correct responses	number	6 weeks
Name to Face Recall reaction time	(ms)	6 weeks
Peg and Ball task Planning time	(ms)	6 weeks
Peg and Ball task Completion time	(ms)	6 weeks
Peg and Ball task errors	Number	6 weeks
Stroop task accuracy		6 weeks
Stroop task reaction time	(ms)	6 weeks
Immediate word recall task correctly identified words	total number (0-15)	6 weeks
Immediate word recall task error responses	total number	6 weeks
Numeric working memory accuracy		6 weeks
Numeric working memory reaction time	(ms)	6 weeks
Choice reaction time accuracy		6 weeks
Choice reaction time reaction time	(ms)	6 weeks
Rapid visual information processing accuracy		6 weeks
Rapid visual information processing reaction time	(ms)	6 weeks
Rapid visual information processing false alarms	number	6 weeks
Corsi blocks accuracy	Average scores from the last five correctly completed trials from the Corsi block-tapping task	6 weeks
Rapid visual information processing accuracy	(%) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Rapid visual information processing reaction time	(ms) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Rapid visual information processing false alarms	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Serial 3 subtractions total responses	number- calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Serial 3 subtractions total error responses	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Serial 7 subtractions total responses	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Serial 7 subtractions total error responses	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Mental fatigue	visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Alertness	visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Alert	derived from Bond Lader visual analogue scale	6 weeks
Content	derived from Bond Lader visual analogue scale	6 weeks
Calm	derived from Bond Lader visual analogue scale	6 weeks

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: DuPont Nutrition and Health

Publications and helpful links

Helpful Links

• Link to study site website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2018
• Primary Completion (ACTUAL): June 10, 2019
• Study Completion (ACTUAL): June 10, 2019

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: gut-brain axis, cognitve demand battery, probiotics
• Other Study ID Numbers: NH-03937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No