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

Not Applicable

Completed

• Conditions: Perceived Stress

• Registration Number: NCT06648980
• Lead Sponsor: Mibelle AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Study Start: 2024-11-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact on perceived stress (PSQ20)	8 weeks	* PSQ = perceived stress questionnaire; * higher scores indicate higher stress levels; * the value range is 0-100

Secondary Outcome Measures

Name	Time	Method
Impact on perceived stress (PSQ20)	4 weeks	* PSQ = perceived stress questionnaire; * higher scores indicate higher stress levels; * the value range is 0-100
Impact on mood (ASTS+VT)	8 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
Global Assessment	8 weeks	* subjective feeling of improvement of perceived stress; * answer options: 'yes' or 'no';
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

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany