Clinical trial NCT06648980: Effect of a Nutritional Supplement With Phytoglycogen on Gut-brain Axis With Focus to Perceived Stress, Mood and Sleep
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceived Stress
Keywords: perceived stress
phytoglycogen
stress
sleep
mood
gut-brain axis
BDNF
Lead sponsor: Mibelle AG
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: Impact on perceived stress (PSQ20)
timeFrame: 8 weeks
Secondary outcomes:
measure: Impact on perceived stress (PSQ20)
timeFrame: 4 weeks
measure: Impact on mood (ASTS+VT)
timeFrame: 4 weeks
measure: Impact on mood (ASTS+VT)
timeFrame: 8 weeks
measure: Impact on sleep (Sleep Questionnaire B/R)
timeFrame: 8 weeks
measure: Impact on quality of life (SF-36)
timeFrame: 8 weeks
measure: Global Assessment
timeFrame: 8 weeks
measure: Blood biomarker
timeFrame: 8 weeks
measure: Impact on emotions (App evaluating emotions)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References: