The Cognitive Effects of 6 Weeks Administration With a Probiotic

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601559
• Other study ID #: NH-03937
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: September 2018
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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+

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Dietary Supplement:
• Lactobacillus paracasei Lpc-37
Live probiotic bacteria
• Placebo
Inert placebo matched for taste and appearance

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	DuPont Nutrition and Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	STAI-state total score	State-trait anxiety inventory 'state' total score (20-80)	6 weeks
Secondary	STAI-trait total score	State-trait anxiety inventory 'trait' total score (20-80)	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Delayed word recall correct	total number of correctly identified words (0-15)	6 weeks
Secondary	Delayed word recall errors	total number of error responses	6 weeks
Secondary	Picture recognition reaction time	(ms)	6 weeks
Secondary	Picture recognition accuracy		6 weeks
Secondary	Word recognition reaction time	(ms)	6 weeks
Secondary	Word recognition accuracy		6 weeks
Secondary	Name to Face Recall correct responses	number	6 weeks
Secondary	Name to Face Recall reaction time	(ms)	6 weeks
Secondary	Peg and Ball task Planning time	(ms)	6 weeks
Secondary	Peg and Ball task Completion time	(ms)	6 weeks
Secondary	Peg and Ball task errors	Number	6 weeks
Secondary	Stroop task accuracy		6 weeks
Secondary	Stroop task reaction time	(ms)	6 weeks
Secondary	Immediate word recall task correctly identified words	total number (0-15)	6 weeks
Secondary	Immediate word recall task error responses	total number	6 weeks
Secondary	Numeric working memory accuracy		6 weeks
Secondary	Numeric working memory reaction time	(ms)	6 weeks
Secondary	Choice reaction time accuracy		6 weeks
Secondary	Choice reaction time reaction time	(ms)	6 weeks
Secondary	Rapid visual information processing accuracy		6 weeks
Secondary	Rapid visual information processing reaction time	(ms)	6 weeks
Secondary	Rapid visual information processing false alarms	number	6 weeks
Secondary	Corsi blocks accuracy	Average scores from the last five correctly completed trials from the Corsi block-tapping task	6 weeks
Secondary	Rapid visual information processing accuracy	(%) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Rapid visual information processing reaction time	(ms) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Rapid visual information processing false alarms	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Serial 3 subtractions total responses	number- calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Serial 3 subtractions total error responses	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Serial 7 subtractions total responses	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Serial 7 subtractions total error responses	number - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Mental fatigue	visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Alertness	visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery	6 weeks
Secondary	Alert	derived from Bond Lader visual analogue scale	6 weeks
Secondary	Content	derived from Bond Lader visual analogue scale	6 weeks
Secondary	Calm	derived from Bond Lader visual analogue scale	6 weeks

External Links

•   Link to study site website