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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: IQP-AS-121

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Analyze & Realize GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IQP-AS-121; To be taken once daily dosing of 1 tablet in the morning.	Dietary supplement: IQP-AS-121

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Ralf Uebelhack,, MD, PhD, Analyze & Realize GmbH

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 14, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: INQ/009416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No