Perceived Stress
Conditions
Keywords
perceived stress, phytoglycogen, stress, sleep, mood, gut-brain axis, BDNF
Brief summary
Aim of the study is to investigate the effects of a 8-week supplementation of a phytoglycogen on perceived stress, sleep, mood and emotional wellbeing. Additionally, stress-related biomarker will be evaluated.
Interventions
DIETARY_SUPPLEMENTPlacebo
microcrystalline cellulose; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast
DIETARY_SUPPLEMENTPhytoglycogen
Phytoglycogen; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast
Sponsors
Mibelle AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Women and men * BMI ≥ 19 and ≤ 30 kg/m² * Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology * PSQ20 total score ≥33 * Capable and willing to give written informed consent
Exclusion criteria
* Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases (colitis ulcerosa, Crohn's IBS, peptic ulcers, celiac disease), depression, diabetes, heavy liver disease, immunodeficiency, pancreas insufficiency, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.) * A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure * Regular intake of drugs possibly interfering with this study (e.g. antidepressants, soporifics) within 3 months prior to study start or during study (stable and controlled L-Thyroxin intake would be allowed) * Regular intake of supplements possibly interfering with this study (e.g. cannabidiol, St. John's wort, melatonin, dietary fiber supplements, probiotics etc.) within 4 weeks prior to study start or during the study (stable vitamin D intake would be allowed) * Vegan nutrition * Smoker > 10 cigarettes / day * Blood donation 4 weeks prior to screening visit and during the study * Known pregnancy, breast feeding or intention to become pregnant during the study * Alcohol or drug abuse * Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study * Relevant allergy or known hypersensitivity against compounds of the study products * Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on perceived stress (PSQ20) | 8 weeks | * PSQ = perceived stress questionnaire; * higher scores indicate higher stress levels * the value range is 0-100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on mood (ASTS+VT) | 4 weeks | ASTS: \- aktuelle Stimmungsskala (ger.) = current mood scale (eng.) VT: \- additional items to calculate subscales 'vigour' and 'tension' seven-point rating scale; value range: 19-133; higher values represent a more negative mood state |
| Impact on sleep (Sleep Questionnaire B/R) | 8 weeks | Sleep Questionnaire (Schlaffragebogen B/R) * 31 questions * refers to the last two weeks * 12 subscales Part B; revised Value range for subscales: 1-5 higher values represent more intense characteristics |
| Impact on quality of life (SF-36) | 8 weeks | * short form 36 (SF-36) health survey * assessment of quality of life * value range is 0-100 * higher total scores indicate a better quality of life |
| Impact on perceived stress (PSQ20) | 4 weeks | * PSQ = perceived stress questionnaire; * higher scores indicate higher stress levels * the value range is 0-100 |
| Blood biomarker | 8 weeks | BDNF (brain derived neurotrophic factor) and hsCRP |
| Impact on emotions (App evaluating emotions) | 8 weeks | * assessment of baseline emotions and triggered emotional change * 5 dimensions are covered |
| Global Assessment | 8 weeks | * subjective feeling of improvement of perceived stress * answer options: 'yes' or 'no'; |
Countries
Germany
Outcome results
None listed