The Cognitive Effects of 6 Weeks Administration With a Probiotic

NCT03601559 | Completed DMC

• 1 other identifier: NH-03937
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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+

Conditions

Cognitive Change

Keywords

gut-brain axis, cognitve demand battery, probiotics

Outcome Measures

Primary Outcomes (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)

  6 weeks

Secondary Outcomes (41)

• STAI-state total score

  6 weeks

• STAI-trait total score

  6 weeks

• Accuracy of attention score

  6 weeks

• Speed of attention score

  6 weeks

• Working memory score

  6 weeks

Study Arms (2)

Lactobacillus paracasei Lpc-37

ACTIVE COMPARATOR

Probiotic

Dietary Supplement: Lactobacillus paracasei Lpc-37

Placebo

PLACEBO COMPARATOR

Inert placebo

Dietary Supplement: Placebo

Interventions

Lactobacillus paracasei Lpc-37 DIETARY_SUPPLEMENT

Live probiotic bacteria

Lactobacillus paracasei Lpc-37

Placebo DIETARY_SUPPLEMENT

Inert placebo matched for taste and appearance

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northumbria University: lead
• DuPont Nutrition and Health: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Links

• Link to study site website

Study Officials

• Philippa A Jackson, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 26, 2018
• Study Start: August 31, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: June 18, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)