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

NCT06648980 | Completed

• 1 other identifier: BTS2118/24
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Perceived Stress

Keywords

perceived stress; phytoglycogen; stress; sleep; mood; gut-brain axis; BDNF

Outcome Measures

Primary Outcomes (1)

• Impact on perceived stress (PSQ20)

  * PSQ = perceived stress questionnaire; * higher scores indicate higher stress levels * the value range is 0-100

  8 weeks

Secondary Outcomes (8)

• Impact on perceived stress (PSQ20)

  4 weeks

• Impact on mood (ASTS+VT)

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose

Dietary Supplement: Placebo

Phytoglycogen

ACTIVE COMPARATOR

Phytoglycogen

Dietary Supplement: Phytoglycogen

Interventions

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast

Placebo

Phytoglycogen DIETARY_SUPPLEMENT

Phytoglycogen; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast

Phytoglycogen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mibelle AG: lead

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Study Officials

• Daniel Menzel, MD

  BioTeSys GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 18, 2024
• Study Start: November 4, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)