Effect of Taking Probiotics and Synbiotics on Physical and Psychological Health and Cognitive Functions in Adults: An Experimental Study

Not Applicable

• Conditions: Anxiety; Depression; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12621001131842
• Lead Sponsor: Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-23
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

BMI falls within the Healthy Weight range (higher than or equal to 18.5 kg/m2 and lower than or equal to 24.9 kg/m2);
Not self-identified as using insulin, vitamin supplements, nutritional supplements (e.g., antioxidant or omega 3), probiotics or prebiotics products, gastrointestinal drugs;
Not receiving any treatment involving experimental drugs, antibiotics, pharmaceuticals;
Without a current or past history of acute or chronic illness, for example, chronic kidney disease, lung disease, and chronic or acute inflammatory disease, hepatic diseases, thyroid diseases, renal diseases, severe intestinal disease, celiac disease, peptic ulcer, gastrointestinal illness, functional dyspepsia (Rome IV classification), diseases or operations affecting digestion, absorption, or defecation, immunodeficiency, bleeding disorder or coagulopathy, cardiovascular diseases, respiratory diseases, heart attack, stroke, diabetes;
Without a current or past history of mental illness, a diagnosis of mental retardation, medical conditions affecting brain or cognitive functioning;
Without a current or past history of food allergies;
Without a current or past history of substance abuse or dependence (inc. alcohol, cigarette, marijuana, opiates), or intravenous drug use;
Not pregnant and lactation or planning to become pregnant during the study period;
Not being a shift worker;
Not participating in an investigational drug trial or another study that would interfere with study objectives or confound the interpretation of the study results during last two months;
Not regular ingestion of probiotics, prebiotics;
Not following a diet or taking a medication.
Being proficient in English;
self-identification as being Australian;
in good health.

Exclusion Criteria

Regular ingestion of fermented foods;
Habitual tobacco/nicotine user (daily tobacco/nicotine user of any amount);
Regular coffee/tea consumption of 5 cups or more per day;
Habitual alcohol drinker (2 or more than 2 standard alcohol drinks per day);
Surgery during the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of experiencing depression assessed by the short version of the Depression, Anxiety and Stress Scales[Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks, primary endpoint)];Change in severity of experiencing anxiety assessed by the short version of the Depression, Anxiety and Stress Scales[Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks, primary endpoint)];Change in severity of experiencing stress assessed by the short version of the Depression, Anxiety and Stress Scales[Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks, primary endpoint)]