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

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

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 Overview

• Status: Completed
• Conditions: Perceived Stress
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Phytoglycogen

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Microcrystalline cellulose	Dietary supplement: Placebo; microcrystalline cellulose; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast
Active Comparator: Phytoglycogen	Dietary supplement: Phytoglycogen; Phytoglycogen; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on perceived stress (PSQ20)	PSQ = perceived stress questionnaire;; higher scores indicate higher stress levels; the value range is 0-100	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on perceived stress (PSQ20)	PSQ = perceived stress questionnaire;; higher scores indicate higher stress levels; the value range is 0-100	4 weeks
Impact on mood (ASTS+VT)	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	4 weeks
Impact on mood (ASTS+VT)	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	8 weeks
Impact on sleep (Sleep Questionnaire B/R)	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	8 weeks
Impact on quality of life (SF-36)	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	8 weeks
Global Assessment	subjective feeling of improvement of perceived stress; answer options: 'yes' or 'no';	8 weeks
Blood biomarker	BDNF (brain derived neurotrophic factor) and hsCRP	8 weeks
Impact on emotions (App evaluating emotions)	assessment of baseline emotions and triggered emotional change; 5 dimensions are covered	8 weeks

Collaborators and Investigators

• Sponsor: Mibelle AG
• Investigators: Principal Investigator: Daniel Menzel, MD, BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: sleep; stress; BDNF; mood; gut-brain axis; perceived stress; phytoglycogen
• Other Study ID Numbers: BTS2118/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No