Clinical trial NCT02871271: Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness
Official title: Open-Label Pilot Study to Evaluate the Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fatigue
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Caucasian males and females, 21-55 years of age
2. Body mass index (BMI) 18.5-29.9 kg/m2
3. Generally in good health without clinically significant findings at screening
4. No chronic fatigue syndrome according to the Fukuda Centres for Disease Control and Prevention (CDC) criteria at screening
5. Subjective feeling of chronic stress and tiredness for 3-12 last months prior to screening
6. Screening Scale of Chronic Stress (SSCS) score \>18
7. Fatigue Severity Scale score \>4
8. ≤ 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
9. Regular stable continuous level of daily activities
10. Regular sleep-wake cycle
11. Normal dietary habits according to investigator's judgement
12. ≤ moderate level of physical exercise
13. 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
14. No change in smoking habits during the study
15. Women of child-bearing potential only:

    1. negative pregnancy testing (ß-HCG in urine at screening)
    2. 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:

1. Known sensitivity to any components of the IP
2. Any medical condition associated with tiredness (e.g. iron deficiency, hypotension etc.)
3. 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:

   1. Psychiatric diseases, e.g. depression, schizophrenia
   2. Eating disorders such as anorexia
   3. Untreated or non-stabilized metabolic diseases, e.g. diabetes mellitus
   4. Untreated or non-stabilized thyroid disorder
   5. Untreated or non-stabilized hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg)
   6. Significant gastrointestinal diseases
   7. Insomnia
   8. Known bleeding disorders such as haemophilia
   9. 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.)
4. 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
5. 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
6. Consumption of adaptogens (e.g. ginseng or Schisandra) or St. John's Wort within last 4 weeks prior to screening and during the study
7. Consumption of energy drinks during the study
8. Start of use of contraception medication during the last 3 months prior to screening and during the study
9. Use of anticoagulants such as warfarin
10. Clinically significant deviation of laboratory parameters and/or deviations \> 2 x ULN (upper limit of normal) at screening
11. Recent or current significant stressors (e.g. active grieving)
12. Chronic pain
13. Chronic sleep deficiency (\< 5 hours/night)
14. 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)
15. Drug abuse
16. Participation in another study during the last 30 days prior to screening
17. Women of child-bearing potential: pregnant or breastfeeding
18. Any situation expected during the study causing acute high level of stress
19. Any other reason deemed suitable for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Primary outcomes:
measure: Change in VAS-F parameter
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Bond & Lader VAS parameter
timeFrame: 6 weeks
measure: Change in Number Connection Test
timeFrame: 6 weeks
measure: Change in FAIR-2
timeFrame: 6 weeks
measure: Change in SF-12 parameter
timeFrame: 6 weeks
measure: Change in PSQ20 parameter
timeFrame: 6 weeks
measure: Change in POMS-35 parameters
timeFrame: 6 weeks
measure: Global evaluation of benefit
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
measure: Global evaluation of tolerability
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
Study officials:
affiliation: analyze & realize GmbH
name: Ralf Uebelhack,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: