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

Not Applicable

Withdrawn

• Conditions: Fatigue
• Interventions: Dietary Supplement: IQP-AS-121

• Registration Number: NCT02871271
• Lead Sponsor: InQpharm Group

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-14
• Study First Posted: 2016-08-18
• Study Start: 2016-11
• Primary Completion: 2017-03
• Study Completion: 2017-09
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IQP-AS-121	IQP-AS-121	To be taken once daily dosing of 1 tablet in the morning.

Primary Outcome Measures

Name	Time	Method
Change in VAS-F parameter	6 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Change in Bond & Lader VAS parameter	6 weeks	Compared between timepoints week 6 versus baseline; - To assess alertness, contentedness and calmness
Change in FAIR-2	6 weeks	Compared between timepoints week 6 versus baseline; - To measure attention as an ability to concentrate
Global evaluation of benefit	6 weeks	Assessed by the subjects and investigator at the end of study; - To evaluate benefit of IP
Adverse events	6 weeks	Assessed throughout the study
Change in SF-12 parameter	6 weeks	Compared between timepoints week 6 versus baseline; - To measure the overall health status of a subject
Change in Number Connection Test	6 weeks	Compared between timepoints week 6 versus baseline; - To assess visuo-spatial orientation and cognitive processing speed.
Change in PSQ20 parameter	6 weeks	Compared between timepoints week 6 versus baseline; - Contained 30 items as an instrument to assess subjectively experienced stress
Change in POMS-35 parameters	6 weeks	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.
Global evaluation of tolerability	6 weeks	Assessed by the subjects and investigator at the end of study

Trial Locations

Locations (1)

analyze & realize GmbH; 🇩🇪 Berlin, Germany