Perceived StressNCT06648980
Effect of a Nutritional Supplement With Phytoglycogen on Gut-brain Axis With Focus to Perceived Stress, Mood and Sleep
A study testing Phytoglycogen in people with Perceived Stress, run by Mibelle AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perceived Stress
- What is being tested?
- Phytoglycogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Placebo, Phytoglycogen
- Keywords
- perceived stress, phytoglycogen, stress, sleep, mood, gut-brain axis, BDNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
microcrystalline cellulose; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast
PhytoglycogenDietary supplement
Phytoglycogen; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Microcrystalline cellulose Receives: Dietary Supplement: Placebo |
| Phytoglycogen | Active comparator | Phytoglycogen Receives: Dietary Supplement: Phytoglycogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on perceived stress (PSQ20)
- PSQ = perceived stress questionnaire;
- higher scores indicate higher stress levels
- the value range is 0-100
Measured: 8 weeks
Secondary outcomes (8)
Impact on perceived stress (PSQ20)
- PSQ = perceived stress questionnaire;
- higher scores indicate higher stress levels
- the value range is 0-100
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks
Global Assessment
- subjective feeling of improvement of perceived stress
- answer options: 'yes' or 'no';
Measured: 8 weeks
Blood biomarker
BDNF (brain derived neurotrophic factor) and hsCRP
Measured: 8 weeks
Impact on emotions (App evaluating emotions)
- assessment of baseline emotions and triggered emotional change
- 5 dimensions are covered
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mibelle AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, MD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648980
- Sponsor's protocol ID
- BTS2118/24
- Status last verified
- May 2025
- First submitted
- 27 Sep 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06648980
- Acronym / sponsor ID
- BTS2118/24
- Conditions
- Perceived Stress
- Keywords
- perceived stress, phytoglycogen, stress, sleep, mood, gut-brain axis, BDNF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mibelle AGIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMicrocrystalline cellulose |
| Phytoglycogen | Active comparator | Dietary Supplement: PhytoglycogenPhytoglycogen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebomicrocrystalline cellulose; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast | Dietary supplement | Placebo |
| PhytoglycogenPhytoglycogen; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast | Dietary supplement | Phytoglycogen |
Primary outcome
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
8 secondary outcomes
Impact on perceived stress (PSQ20)
Time frame: 4 weeks
Impact on mood (ASTS+VT)
Time frame: 4 weeks
Impact on mood (ASTS+VT)
Time frame: 8 weeks
Impact on sleep (Sleep Questionnaire B/R)
Time frame: 8 weeks
Impact on quality of life (SF-36)
Time frame: 8 weeks
Global Assessment
Time frame: 8 weeks
Blood biomarker
Time frame: 8 weeks
Impact on emotions (App evaluating emotions)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Menzel, MD principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytoglycogen in people with Perceived Stress, run by Mibelle AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on perceived stress (PSQ20) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.