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

Effect of Taking Probiotics and Synbiotics on Physical and Psychological Health and Cognitive Functions in Adults: A Blind, Randomised, Placebo-Controlled Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001131842
Enrollment
144
Registered
2021-08-23
Start date
2021-10-25
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Depression and anxiety are some of the major mental health problems negatively affecting the physical and mental health of many individuals. Recent research suggests a possible therapeutic impact of taking probiotics as dietary supplements on symptoms of depression and anxiety. This study extends the current knowledge on the beneficial effects of taking dietary supplements on health by comparing the effect of taking probiotics and taking synbiotics and exploring potential mediating factors (e.g., cognitive function, personality, etc.).

Interventions

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.

Sponsors

Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026