Cognitive and Metabolic Effects of a Probiotic Supplement

NCT02005003 | Unknown

• 1 other identifier: FF8vsPlaceboJC2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the cognitive and metabolic effects of a probiotic supplement that is readily and already available for purchase in public drug stores. This study is a double-blinded randomized cross-over placebo-controlled intervention study. Participants will be randomized to receive either the probiotic supplement or the placebo during the first intervention period which will last 2 weeks. This will be followed by a washout period, after which they will proceed to the second intervention period, also lasting 2 weeks and also followed by a washout period.

Conditions

Dietary Supplements; Probiotics; Metabolism; Food Preferences; Microbiota

Outcome Measures

Primary Outcomes (1)

• Memory function

  Memory test to examine the influence of probiotic supplement compared with placebo on memory function (declarative and working memory)

  Change in memory function assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)

Secondary Outcomes (6)

• Glycometabolic regulation

  Change in glycometabolic regulation assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)

• Food preferences

  Change in food preferences assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)

• Inhibitory task

  Change in inhibitory task performance assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)

• Food consumption task

  Change in food consumption task assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)

• Sleep patterns

  Change in sleep patterns as assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic pills given for 2 weeks, during one of the interventions that the participants is either randomized to as the first or second intervention period. At day 0 and following each intervention period (at week 2 and week 6), participants will be tested using Inhibitory task, Blood samples, Feces collection, Caloric preload, Food selection task, Memory task and Food consumption task.

Behavioral: Inhibitory task; Procedure: Blood samples; Biological: Feces collection; Procedure: Caloric preload; Behavioral: Food selection task; Behavioral: Memory task; Behavioral: Food consumption task

Placebo

PLACEBO COMPARATOR

Placebo pills given for 2 weeks, during one of the interventions that the participants is either randomized to as the first or second intervention period. At day 0 and following each intervention period (at week 2 and week 6), participants will be tested using Inhibitory task, Blood samples, Feces collection, Caloric preload, Food selection task, Memory task and Food consumption task.

Behavioral: Inhibitory task; Procedure: Blood samples; Biological: Feces collection; Procedure: Caloric preload; Behavioral: Food selection task; Behavioral: Memory task; Behavioral: Food consumption task

Interventions

Inhibitory task BEHAVIORAL

Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event

Placebo; Probiotic

Blood samples PROCEDURE

Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit

Placebo; Probiotic

Feces collection BIOLOGICAL

Feces samples will be collected on the morning of each visit, before and after each 2-week intervention period, as well as after each 2-week washout period following each intervention period.

Placebo; Probiotic

Caloric preload PROCEDURE

A caloric preload will be given to participants, following which blood will be taken at 65 minutes later (specified in Blood sampling) following the ingestion of the caloric preload.

Placebo; Probiotic

Food selection task BEHAVIORAL

Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume

Placebo; Probiotic

Memory task BEHAVIORAL

Participants perform short memory tasks on each visit

Placebo; Probiotic

Food consumption task BEHAVIORAL

Participants are given a selection of food items to consume on each visit

Placebo; Probiotic

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age 18-28y
• Healthy (self-reported) and not on medication
• Non-smoking
• Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)
• Regular meal patterns with daily breakfast

You may not qualify if:

• Major illness
• Taking any serious medications
• Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
• Any dietary issues with the food items provided
• Current or history of endocrine, neurological or psychiatric disorders
• Shift work in the preceding three months or for a long duration
• Time travel over a significant number of time zones in the preceding two months
• Too much weight gain or weight loss in the preceding three months
• Excessive intake of fermented dairy products
• Intake of probiotics
• Recent antibiotic treatment (last 6 months)
• Recent intake of certain dietary supplements
• Excessive caffeine (\>5 cups daily) or alcohol intake (\>2 alcohol units daily)

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of Neuroscience, Uppsala University

Uppsala, 75324, Sweden

RECRUITING

MeSH Terms

Conditions

Food Preferences

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christian Benedict, PhD

  Department of Neuroscience, Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Cedernaes, M.D., PhD

CONTACT

jonathan.cedernaes@neuro.uu.se

Christian Benedict, PhD

CONTACT

christian.benedict@neuro.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

SE (1)