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FatigueNCT02871271

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

A study testing IQP-AS-121 in people with Fatigue, run by InQpharm Group at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Fatigue
What is being tested?
IQP-AS-121
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteGermany
Study dates
Nov 2016to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • analyze & realize GmbH

    Berlin, 10369

Other trials in Germany

About this study

Official title: 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.

Conditions
Fatigue
Being tested
IQP-AS-121
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IQP-AS-121Dietary supplement

Study groups in NCT02871271
Study groupRoleWhat they receive
IQP-AS-121ExperimentalTo be taken once daily dosing of 1 tablet in the morning.
Receives: Dietary Supplement: IQP-AS-121

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 weeks

Secondary outcomes (9)

  1. Change in Bond & Lader VAS parameter

    Compared between timepoints week 6 versus baseline

    • To assess alertness, contentedness and calmness

    Measured: 6 weeks

  2. Change in Number Connection Test

    Compared between timepoints week 6 versus baseline

    • To assess visuo-spatial orientation and cognitive processing speed.

    Measured: 6 weeks

  3. Change in FAIR-2

    Compared between timepoints week 6 versus baseline

    • To measure attention as an ability to concentrate

    Measured: 6 weeks

  4. Change in SF-12 parameter

    Compared between timepoints week 6 versus baseline

    • To measure the overall health status of a subject

    Measured: 6 weeks

  5. Change in PSQ20 parameter

    Compared between timepoints week 6 versus baseline

    • Contained 30 items as an instrument to assess subjectively experienced stress

    Measured: 6 weeks

  6. 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.

    Measured: 6 weeks

  7. Global evaluation of benefit

    Assessed by the subjects and investigator at the end of study

    • To evaluate benefit of IP

    Measured: 6 weeks

  8. Adverse events

    Assessed throughout the study

    Measured: 6 weeks

  9. Global evaluation of tolerability

    Assessed by the subjects and investigator at the end of study

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study startNov 2016 (estimated)
  3. Primary completionMar 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Why it stopped: Stopped product production

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871271
Sponsor's protocol ID
INQ/009416
Status last verified
Jul 2016
First submitted
10 Aug 2016
Last updated
12 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IQP-AS-121 in people with Fatigue, run by InQpharm Group at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VAS-F parameter (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.

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