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Completed

NCT Number: NCT06648980

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

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.

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Key information

Conditions

Perceived Stress

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Phytoglycogen

Dietary Supplement

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

Primary outcomes

  1. Impact on perceived stress (PSQ20)

    Time frame: 8 weeks

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

Secondary outcomes

  1. Impact on perceived stress (PSQ20)

    Time frame: 4 weeks

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

  2. Impact on mood (ASTS+VT)

    Time frame: 4 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

  3. Impact on mood (ASTS+VT)

    Time frame: 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

  4. Impact on sleep (Sleep Questionnaire B/R)

    Time frame: 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

  5. Impact on quality of life (SF-36)

    Time frame: 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

  6. Global Assessment

    Time frame: 8 weeks

    • subjective feeling of improvement of perceived stress
    • answer options: 'yes' or 'no';

  7. Blood biomarker

    Time frame: 8 weeks

    BDNF (brain derived neurotrophic factor) and hsCRP

  8. Impact on emotions (App evaluating emotions)

    Time frame: 8 weeks

    • assessment of baseline emotions and triggered emotional change
    • 5 dimensions are covered

Sponsors and collaborators

Lead sponsor

Mibelle AG

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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