NCT06648980CompletedNot Applicable
Effect of a Nutritional Supplement With Phytoglycogen on Gut-brain Axis With Focus to Perceived Stress, Mood and Sleep: a Randomized, Double-blind, Placebo-controlled Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mibelle AG
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Impact on perceived stress (PSQ20)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Phytoglycogen
Active Comparator
Phytoglycogen
Intervention: Phytoglycogen (Dietary Supplement)
Placebo
Placebo Comparator
Microcrystalline cellulose
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Impact on perceived stress (PSQ20)
Time Frame: 8 weeks
* PSQ = perceived stress questionnaire; * higher scores indicate higher stress levels * the value range is 0-100
Secondary Outcomes
- Impact on perceived stress (PSQ20)(4 weeks)
- Impact on mood (ASTS+VT)(8 weeks)
- Impact on sleep (Sleep Questionnaire B/R)(8 weeks)
- Impact on quality of life (SF-36)(8 weeks)
- Global Assessment(8 weeks)
- Blood biomarker(8 weeks)
- Impact on emotions (App evaluating emotions)(8 weeks)
- Impact on mood (ASTS+VT)(4 weeks)
Investigators
Study Sites (1)
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