Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001131842
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Taking Probiotics and Synbiotics on Physical and Psychological Health and Cognitive Functions in Adults: An Experimental Study
Scientific title
Effect of Taking Probiotics and Synbiotics on Physical and Psychological Health and Cognitive Functions in Adults: A Blind, Randomised, Placebo-Controlled Study
Secondary ID [1] 304717 0
Nil
Universal Trial Number (UTN)
U1111-1267-7576
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 322946 0
Depression 322947 0
Condition category
Condition code
Mental Health 320515 320515 0 0
Anxiety
Mental Health 320516 320516 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants, who are randomly assigned to the Probiotics group, will be instructed to take 1 probiotics capsule per day for a period of 8 weeks. Each capsule contains a mixture of 1x109 CFU of Lactobacillus acidophilus, 1x109 CFU of Lactobacillus casei, 1x109 CFU of Bifidobacterium longum, and 1x109 CFU of Lactobacillus helveticus.

Participants, who are randomly assigned to the Synbiotics group, will be instructed to take 1 Synbiotics capsule per day for a period of 8 weeks. Each capsule contains a mixture of 1x109 CFU of Lactobacillus acidophilus, 1x109 CFU of Lactobacillus casei, 1x109 CFU of Bifidobacterium longum, 1x109 CFU of Lactobacillus helveticus, and 100mg of Inulin.

Adherence will be monitored by capsule counts (participants will be instructed to return the container of the supplement and the researcher will count and record the capsules remain in the container) and self-reported capsule taking record by participants.
Intervention code [1] 321242 0
Treatment: Other
Comparator / control treatment
Participants, who are randomly assigned to the control group, will be instructed to take 1 placebo capsule per day for a period of 8 weeks. Each capsule contains non-active ingredients including maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 328359 0
Change in severity of experiencing depression assessed by the short version of the Depression, Anxiety and Stress Scales
Timepoint [1] 328359 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks, primary endpoint)
Primary outcome [2] 328360 0
Change in severity of experiencing anxiety assessed by the short version of the Depression, Anxiety and Stress Scales
Timepoint [2] 328360 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks, primary endpoint)
Primary outcome [3] 328361 0
Change in severity of experiencing stress assessed by the short version of the Depression, Anxiety and Stress Scales
Timepoint [3] 328361 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks, primary endpoint)
Secondary outcome [1] 398708 0
Change in Psychological well-being assessed by the World Health Organization-Five Well-Being Index
Timepoint [1] 398708 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [2] 398709 0
Change in quality of life assessed by the short form 12 health survey
Timepoint [2] 398709 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [3] 398727 0
Change in body composition assessed by a body composition analyser
Timepoint [3] 398727 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [4] 398728 0
Change in body mass index calculated by using participants’ height and weight. Height will be measured with a measuring tape. Weight will be measured using a digital scale
Timepoint [4] 398728 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [5] 398729 0
Change in cognitive function assessed by performance in Stroop test
Timepoint [5] 398729 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [6] 398730 0
Change in functional limitations attributed to fatigue assessed by the Fatigue Impact Scale
Timepoint [6] 398730 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [7] 398731 0
Change in cognitive regulation of emotions attributed to fatigue assessed by the Cognitive Emotion Regulation Questionnaire
Timepoint [7] 398731 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [8] 398732 0
Change in scores of personality traits assessed by the International Personality Item Pool-Five-Factor Model inventory
Timepoint [8] 398732 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [9] 398733 0
Change in a composite score of physical symptoms and somatic symptoms assessed by the Patient Health Questionnaire
Timepoint [9] 398733 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [10] 398734 0
Change in the amount of adverse reactions/events assessed by answering questions about known/possible adverse reactions/events (e.g., How much have you been bothered by bloating?) and questions about use of health services and taking medications.
Timepoint [10] 398734 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [11] 398736 0
Change in dietary pattern assessed by the short Food Frequency Questionnaire
Timepoint [11] 398736 0
Pre-intervention, baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [12] 398739 0
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index
Timepoint [12] 398739 0
Pre-intervention, baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [13] 398748 0
Change in the amount of physical activity assessed by the Short Form of International Physical Activity Questionnaire
Timepoint [13] 398748 0
Pre-intervention, baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [14] 399568 0
Change in Waist-to-height ratio calculated by using participants’ height and waist circumference. Height and waist circumference will be measured with a measuring tape.
Timepoint [14] 399568 0
Pre-intervention, baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [15] 399572 0
Change in cognitive function assessed by performance in Emotional Stroop test
Timepoint [15] 399572 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [16] 399573 0
Change in cognitive function assessed by performance in choice reaction time test
Timepoint [16] 399573 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcome [17] 399574 0
Change in cognitive function assessed by performance in digit span test
Timepoint [17] 399574 0
Baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The capsules are packed in identical bottles. Bottles are labelled clearly with different letters. The corresponding letter of each product is arranged by the company, which supplies the capsules for this study, The information about the corresponding letter of each product is sealed in opaque envelopes throughout the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence is generated using a computer-based random sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/10/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309087 0
University
Name [1] 309087 0
Macquarie University
Country [1] 309087 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 310035 0
None
Name [1] 310035 0
Address [1] 310035 0
Country [1] 310035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308961 0
Macquarie University Human Research Ethics Committee EXEC Medical Sciences Committee
Ethics committee address [1] 308961 0
Ethics committee country [1] 308961 0
Australia
Date submitted for ethics approval [1] 308961 0
05/05/2021
Approval date [1] 308961 0
16/07/2021
Ethics approval number [1] 308961 0
52021992429051

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112486 0
Miss Catie Lai
Address 112486 0
Department of Psychology | 4FW Room 403
Faculty of Medicine, Health and Human Sciences
Macquarie University, NSW 2109, Australia
Country 112486 0
Australia
Phone 112486 0
+61432099119
Fax 112486 0
Email 112486 0
[email protected]
Contact person for public queries
Name 112487 0
Catie Lai
Address 112487 0
Department of Psychology | 4FW Room 403
Faculty of Medicine, Health and Human Sciences
Macquarie University, NSW 2109, Australia
Country 112487 0
Australia
Phone 112487 0
+61432099119
Fax 112487 0
Email 112487 0
[email protected]
Contact person for scientific queries
Name 112488 0
Catie Lai
Address 112488 0
Department of Psychology | 4FW Room 403
Faculty of Medicine, Health and Human Sciences
Macquarie University, NSW 2109, Australia
Country 112488 0
Australia
Phone 112488 0
+61432099119
Fax 112488 0
Email 112488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with ethical guidelines only the research team will have access to individual level participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12650Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.