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Cognitive ChangeNCT03601559

The Cognitive Effects of 6 Weeks Administration With a Probiotic

A study testing Lactobacillus paracasei Lpc-37 in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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+ Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Change
What is being tested?
Lactobacillus paracasei Lpc-37
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
31 Aug 2018to 10 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Male or female, aged ≥ 65 years
  • Willing and able to provide written and informed consent
  • 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
  • Agreement to comply with the protocol and study restrictions
  • Available for all study visits
  • In good general health, self-reported and as judged by the Principal Investigator/Clinical advisor based on medical history
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  • Fluent in written and spoken English
  • Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period
  • Has a bank account (required for payment)

Who cannot join

  • 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
  • History of dementia, stroke and other neurological conditions
  • Traumatic loss of consciousness in the last 12 months
  • History of epilepsy or Parkinson's disease
  • 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
  • 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
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  • 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
  • Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
  • 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
  • Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
  • Have a Body Mass Index (BMI) outside of the range 18.5-29.9 kg/m2
  • Have learning difficulties, dyslexia
  • Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
  • Current smoker (use of nicotine replacement products, vaping, gum, patches etc)
  • Have a history of alcohol or drug abuse
  • Current misuse of alcohol, drug or prescription medications
  • Excessive caffeine intake (>500 mg per day)
  • 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
  • Contraindication to any substance in the investigational product
  • Principal Investigator believes that the participant may be uncooperative and / or noncompliant and should therefore not participate in the study
  • Participant under legal or administrative supervision
  • Have food intolerances / sensitivities
  • Have any health condition that would prevent fulfilment of the study requirements
  • Are unable or unwilling to complete all the study assessments
  • Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Northumbria University

    Newcastle upon Tyne, Tyne and Wear, NE1 8ST

Other trials in United Kingdom

About this study

Official title: 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+

Being tested
Lactobacillus paracasei Lpc-37, Placebo
Keywords
gut-brain axis, cognitve demand battery, probiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactobacillus paracasei Lpc-37Dietary supplement

    Live probiotic bacteria

  • PlaceboDietary supplement

    Inert placebo matched for taste and appearance

Study groups in NCT03601559
Study groupRoleWhat they receive
Lactobacillus paracasei Lpc-37Active comparatorProbiotic
Receives: Dietary Supplement: Lactobacillus paracasei Lpc-37
PlaceboPlacebo comparatorInert placebo
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 weeks

Secondary outcomes (41)

  1. STAI-state total score

    State-trait anxiety inventory 'state' total score (20-80)

    Measured: 6 weeks

  2. STAI-trait total score

    State-trait anxiety inventory 'trait' total score (20-80)

    Measured: 6 weeks

  3. 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)

    Measured: 6 weeks

  4. 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)

    Measured: 6 weeks

  5. 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)

    Measured: 6 weeks

  6. 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)

    Measured: 6 weeks

  7. Delayed word recall correct

    total number of correctly identified words (0-15)

    Measured: 6 weeks

  8. Delayed word recall errors

    total number of error responses

    Measured: 6 weeks

  9. Picture recognition reaction time

    (ms)

    Measured: 6 weeks

  10. Picture recognition accuracy

    Measured: 6 weeks

  11. Word recognition reaction time

    (ms)

    Measured: 6 weeks

  12. Word recognition accuracy

    Measured: 6 weeks

  13. Name to Face Recall correct responses

    number

    Measured: 6 weeks

  14. Name to Face Recall reaction time

    (ms)

    Measured: 6 weeks

  15. Peg and Ball task Planning time

    (ms)

    Measured: 6 weeks

  16. Peg and Ball task Completion time

    (ms)

    Measured: 6 weeks

  17. Peg and Ball task errors

    Number

    Measured: 6 weeks

  18. Stroop task accuracy

    Measured: 6 weeks

  19. Stroop task reaction time

    (ms)

    Measured: 6 weeks

  20. Immediate word recall task correctly identified words

    total number (0-15)

    Measured: 6 weeks

  21. Immediate word recall task error responses

    total number

    Measured: 6 weeks

  22. Numeric working memory accuracy

    Measured: 6 weeks

  23. Numeric working memory reaction time

    (ms)

    Measured: 6 weeks

  24. Choice reaction time accuracy

    Measured: 6 weeks

  25. Choice reaction time reaction time

    (ms)

    Measured: 6 weeks

  26. Rapid visual information processing accuracy

    Measured: 6 weeks

  27. Rapid visual information processing reaction time

    (ms)

    Measured: 6 weeks

  28. Rapid visual information processing false alarms

    number

    Measured: 6 weeks

  29. Corsi blocks accuracy

    Average scores from the last five correctly completed trials from the Corsi block-tapping task

    Measured: 6 weeks

  30. Rapid visual information processing accuracy

    (%) - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  31. Rapid visual information processing reaction time

    (ms) - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  32. Rapid visual information processing false alarms

    number - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  33. Serial 3 subtractions total responses

    number- calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  34. Serial 3 subtractions total error responses

    number - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  35. Serial 7 subtractions total responses

    number - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  36. Serial 7 subtractions total error responses

    number - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  37. Mental fatigue

    visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  38. Alertness

    visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery

    Measured: 6 weeks

  39. Alert

    derived from Bond Lader visual analogue scale

    Measured: 6 weeks

  40. Content

    derived from Bond Lader visual analogue scale

    Measured: 6 weeks

  41. Calm

    derived from Bond Lader visual analogue scale

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start31 Aug 2018
  3. Primary completion10 Jun 2019
  4. Study completion10 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601559
Sponsor's protocol ID
NH-03937
Status last verified
Sep 2018
First submitted
5 Jul 2018
Last updated
18 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lactobacillus paracasei Lpc-37 in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Episodic memory score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03601559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.

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