Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the tolerability and benefit of IQP-AS-121 on reducing fatigue and tiredness and to improve mental alertness.

Official Title
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Open-Label Pilot Study to Evaluate the Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness in Healthy Subjects

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: IQP-AS-121


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian males and females, 21-55 years of age Body mass index (BMI) 18.5-29.9 kg/m2 Generally in good health without clinically significant findings at screening No chronic fatigue syndrome according to the Fukuda Centres for Disease Control and Prevention (CDC) criteria at screening Subjective feeling of chronic stress and tiredness for 3-12 last months prior to screening Screening Scale of Chronic Stress (SSCS) score >18 Fatigue Severity Scale score >4 ≤ 3 cups/portions of coffee and/or caffeine-containing food/beverages per day in the 3 last months prior to screening and during the study Regular stable continuous level of daily activities Regular sleep-wake cycle Normal dietary habits according to investigator's judgement ≤ moderate level of physical exercise Readiness to comply with study procedures, in particular: Consumption of the IP during the treatment period Filling in all questionnaires Keep habitual diet and level of physical exercise No change in smoking habits during the study Women of child-bearing potential only: negative pregnancy testing (ß-HCG in urine at screening) commitment to use reliable contraception methods during the entire study Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. Exclusion Criteria: Known sensitivity to any components of the IP Any medical condition associated with tiredness (e.g. iron deficiency, hypotension etc.) History and/or presence of clinically significant disease, which per investigator's judgement could interfere with the results of the study or the safety of the subject: Psychiatric diseases, e.g. depression, schizophrenia Eating disorders such as anorexia Untreated or non-stabilized metabolic diseases, e.g. diabetes mellitus Untreated or non-stabilized thyroid disorder Untreated or non-stabilized hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) Significant gastrointestinal diseases Insomnia Known bleeding disorders such as haemophilia Any other known significant or serious condition / disease that renders subjects ineligible (e.g. history of malignancy within the past 5 years prior to screening, any clinically significant cardiovascular, renal, liver disease etc.) Use of medication which in the investigator's judgement could interfere with the results of the study (e.g. psychoactive medication, statins, proton pump inhibitors, blood-pressure medications, antihistamines, antibiotics, diuretics) within the last 4 weeks prior to screening and during the study Consumption of vitamins, nutritional supplements, supplementary balanced diet, mineral products which in the investigator's judgement could interfere with the results of the study within last 4 weeks prior to screening and during the study Consumption of adaptogens (e.g. ginseng or Schisandra) or St. John's Wort within last 4 weeks prior to screening and during the study Consumption of energy drinks during the study Start of use of contraception medication during the last 3 months prior to screening and during the study Use of anticoagulants such as warfarin Clinically significant deviation of laboratory parameters and/or deviations > 2 x ULN (upper limit of normal) at screening Recent or current significant stressors (e.g. active grieving) Chronic pain Chronic sleep deficiency (< 5 hours/night) Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) Drug abuse Participation in another study during the last 30 days prior to screening Women of child-bearing potential: pregnant or breastfeeding Any situation expected during the study causing acute high level of stress Any other reason deemed suitable for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQP-AS-121<br>To be taken once daily dosing of 1 tablet in the morning. | Dietary Supplement: IQP-AS-121<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS-F parameter | Compared between timepoints week 6 versus baseline - To assess fatigue and energy with 18 items which possesses two subscales: fatigue (13 items) and energy (5 items). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bond & Lader VAS parameter | Compared between timepoints week 6 versus baseline - To assess alertness, contentedness and calmness | 6 weeks | 
| Change in Number Connection Test | Compared between timepoints week 6 versus baseline - To assess visuo-spatial orientation and cognitive processing speed. | 6 weeks | 
| Change in FAIR-2 | Compared between timepoints week 6 versus baseline - To measure attention as an ability to concentrate | 6 weeks | 
| Change in SF-12 parameter | Compared between timepoints week 6 versus baseline - To measure the overall health status of a subject | 6 weeks | 
| Change in PSQ20 parameter | Compared between timepoints week 6 versus baseline - Contained 30 items as an instrument to assess subjectively experienced stress | 6 weeks | 
| Change in POMS-35 parameters | Compared between timepoints week 6 versus baseline - The POMS-65 comprises 65 adjectives, separated into 6 subscales: 1) depression-dejection, 2) tension-anxiety, 3) anger-hostility, 4) confusion bewilderment, 5) fatigue-inertia and 6) vigour-activity. | 6 weeks | 
| Global evaluation of benefit | Assessed by the subjects and investigator at the end of study - To evaluate benefit of IP | 6 weeks | 
| Adverse events | Assessed throughout the study | 6 weeks | 
| Global evaluation of tolerability | Assessed by the subjects and investigator at the end of study | 6 weeks |