Effect of a Nutritional Supplement With Phytoglycogen on Gut-brain Axis With Focus to Perceived Stress, Mood and Sleep

Mibelle

Status: Completed

Conditions: Perceived Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Phytoglycogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT06648980

BTS2118/24

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Microcrystalline cellulose

Treatment:

Dietary Supplement: Placebo

Phytoglycogen

Active Comparator group

Description:

Phytoglycogen

Treatment:

Dietary Supplement: Phytoglycogen