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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Perceived Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Phytoglycogen

Group Type ACTIVE_COMPARATOR

Phytoglycogen

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Phytoglycogen

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No