Effect of a Nutritional Supplement With Phytoglycogen on... | NCT06648980

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

NCT06648980

Sponsor

Mibelle AG

Status

Completed

Last Update Posted

May 18, 2025Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Perceived Stress

Interventions

Placebo
Phytoglycogen

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2024Actual

Primary Completion Date

Apr 30, 2025Actual

Completion Date

Apr 30, 2025Actual

First Submitted Date

Sep 27, 2024

First Submission Date that Met QC Criteria

Oct 17, 2024

First Posted Date

Oct 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2025

Last Update Posted Date

May 18, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Microcrystalline cellulose	Dietary Supplement: Placebo
Phytoglycogen	Active Comparator	Phytoglycogen	Dietary Supplement: Phytoglycogen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	microcrystalline cellulose; 200 mg /day; 1 capsule/day; 1 capsule daily with breakfast	Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided