To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
Participant is male or female, 50-75 years of age, inclusive.
Participant has a Body Mass Index (BMI) of ≥18.5 kg/m2 to 32 kg/m2.
Participant is generally in good health, as per investigator's judgement at V1.
Participant has subjective mild to moderate memory complaints, as per investigator's judgement.
Participant has a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disease, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.
MMSE score at V1 < 21.
Chronic fatigue syndrome.
Women: elevated stress and/or anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement
Parallel
Humiome Post LB (Postbiotic)
Dietary supplementHeat-inactivated lactobacilli with fermented medium (a postbiotic) in 340mg powder format
Placebo
Dietary supplementMicrocrystalline cellulose, 340mg powder format
Effect on stress
To assess the effect of 3 months of daily consumption of Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
Effect on stress (adjusted to baseline)
To assess the effect of 3 months of daily consumption of Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo. Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome
Effect on stress (within the group)
To assess the effect of 3 months of daily consumption of Humiome® Post LB on change in DASS-21 subscores of stress, depression, anxiety in study participants when compared to placebo (between group comparison) and baseline (withingroup comparison). Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome
Effect on stress (within the group, compared to baseline)
To assess the effect of 3 months of daily consumption of Humiome® Post LB and Placebo on stress measured by the DASS-21 in study participants when compared to baseline. Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome.
Effect on indicators of Anxiety
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of anxiety when compared to placebo and baseline . The GAD-7 total score (range 0-21, expressed in a.u.) will be used to assess indicators of anxiety. Lowest Value: 0 Highest Value: 21. A higher score means a worse outcome
Effect on Musculoskeletal strength
To assess the effect of 3 months of daily consumption of Humiome® Post LB on the Musculoskeletal strength when compared to placebo and baseline. Musculoskeletal strength will measured by grip strength using a hand dynamometer (dominant arm) (expressed in kg).
Effect on Visual-motor coordination
To assess the effect of 3 months of daily consumption of Humiome® Post LB on Visual-motor coordination when compared to placebo and baseline. Visual-motor coordination of study participants (expressed in seconds) will be measured by the "Manipulation and Dexterity Test - Pegboard".
Effect on Indicators of general health and well-being
To assess the effect of 3 months of daily consumption of Humiome® Post LB on Indicators of general health and well-being when compared to placebo and baseline. The SF-12 will be used to assess general health and well-being: physical component summary and mental component summary scales (T score, expressed in a.u.). Lowest Value: 0, Highest Value: 100. A higher score means a better outcome,
Effect on Indicators of sleeping quality status
To assess the effect of 3 months of daily consumption of Humiome® Post LB on Indicators of sleeping quality status when compared to placebo and baseline. The PSQI global score will be used to assess sleep quality (expressed in a.u., range 0-21). Lowest Value: 0, Highest Value: 21. A higher score means a worse outcome
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dsm-firmenich Switzerland AG
Lead sponsor
Analyze & Realize
Collaborator
