The placebo-controlled, double blind parallel intervention trial "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB; 340 mg / day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France.
Men and women aged between 50 and 75 years old (limits included),
Body mass index (BMI) ≥ 18.5 and < 30 kg/m²
Presenting a level of psychological stress characterized by a PSS-10 score ≥ 14 and ≤ 26,
For women: not at risk of pregnancy (as per definitions of Appendix 13) Participants currently of childbearing potential, using an effective method of contraception.
Suffering from a metabolic disorder such as treated or untreated diabetes,
Suffering from thyroid dysfunction, high blood pressure or other metabolic disorders treated for less than 6 months and/or non-stabilized,
Suffering from a severe chronic disease: cancer, HIV, renal failure, hepatic or biliary disorders ongoing (except for cholecystectomy since more than two years and asymptomatic), chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble (except for mild asthma under treatment),
Suffering from GI disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease, Chron's disease, etc.),
Parallel
Humiome Post LB
Dietary supplementHumiome Post LB is a postbiotic preparation according to the 2021 ISAPP definition (PMID: 33948025). It contains heat-treated co-fermented Limosilactobacillus fermentum (CNCM I-4831) and Lactobacillus delbrueckii ssp. lactis (CNCM I-4831), dried together with heat-treated spent fermentation medium on lactose as carrier.
Microcrystalline Cellulose
Other interventionMCC is typically sourced from wood pulp, or it can be chemically synthesized. It consists of linear chains of glucose, which are interlinked with β1,4-glycosidic bonds and cannot be broken by digestive enzymes. It is a very poor substrate for gut micro-organisms and is thus a good material to serve as placebo.
The primary outcome measure is the Perceived Symtoms of Stress 10 (PSS10) questionnaire, which assesses perceived levels of stress
The PSS-10 questionnaire is a validated tool to assess self-reported levels of stress. It was originally developed in 1988 by Cohen and Williamson and published in "The social psychology of health" (pp. 31-67). S. Spacapan \& S. Oskamp (Eds.), Newbury Park, CA: Sage.
Perceived stress (PSS-10) after 6 weeks
Stress will also be assesed with the PSS-10 tool half-way through the intervention (6 weeks)
Sleep quality after 6 and 12 weeks, assessed with the SHI (Sleep Hygiene Index) questionnaire
The SHI questionnaire is a likert-scale questionnaire developed in 2006 (Mastin, D. F., Bryson, J., \& Corwyn, R. (2006). Assessment of sleep hygiene using the Sleep Hygiene Index. Journal of Behavioral Medicine).
Digestive health after 6 and 12 weeks
Digestive health will be assessed with the Gastrointestinal Symptom Rating Score questionnaire (GSRS). It is questionnaire with a 7-point Likert-scale (7 = most severe) with questions related to Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. It was developed by Svedlund et al. (Svedlund J, Sjödin I, Dotevall G. GSRS - A Clinical Rating Scale For Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome and Peptic Ulcer Disease. Digestive Diseases and Sciences 1988; 33:129-134)
Depression, Anxiety and Stress
These are assessed with the DASS-21 questionnaire. It uses a 4-point Likert scale for 21 questions with 7 questions each in the field of depression, anxiety, and stress. It was developed by Lovibond et al. Lovibond, S. H., \& Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales. Sydney: Psychology Foundation of Australia.
Gut Microbiome diversity and function after 6 and 12 weeks
DNA from fecal samples will be shotgun-sequenced (Illumina Hiseq 150 x2) and taxonomic (alpha and beta-diversity) and functional composition assessed by aligning functional gene copy numbers with known database (Kegg). The gut metabolomic profile will be analysed using semi-polar LC-MS / MS methods to detect the abundance of metabolites known or hypothesized to be involved in stress such as GABA, serotonin or melatonin. The faecal organic acids (acetate, propionate, butyrate, valerate, lactate) will be analysed by a targeted quantitative SCFA method (GC-MS).
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dsm-firmenich Switzerland AG
Lead sponsor
BioFortis
Collaborator
