Cognitive and Metabolic Effects of a Probiotic Supplement

Uppsala University

Status: Unknown

Conditions: Metabolism; Probiotics; Food Preferences; Dietary Supplements; Microbiota

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02005003

FF8vsPlaceboJC2013

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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.

Treatment:

Behavioral: Food consumption task

Behavioral: Food selection task

Biological: Feces collection

Behavioral: Memory task

Procedure: Caloric preload

Behavioral: Inhibitory task

Procedure: Blood samples

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Food consumption task

Behavioral: Food selection task

Biological: Feces collection

Behavioral: Memory task

Procedure: Caloric preload

Behavioral: Inhibitory task

Procedure: Blood samples