NCT02871271

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 12, 2020

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

August 10, 2016

Last Update Submit

February 10, 2020

Conditions

Fatigue

Outcome Measures

Primary Outcomes (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).

    6 weeks

Secondary Outcomes (9)

  • Change in Bond & Lader VAS parameter

    6 weeks

  • Change in Number Connection Test

    6 weeks

  • Change in FAIR-2

    6 weeks

  • Change in SF-12 parameter

    6 weeks

  • Change in PSQ20 parameter

    6 weeks

  • +4 more secondary outcomes

Study Arms (1)

IQP-AS-121

EXPERIMENTAL

To be taken once daily dosing of 1 tablet in the morning.

Dietary Supplement: IQP-AS-121

Interventions

IQP-AS-121DIETARY_SUPPLEMENT
IQP-AS-121

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ralf Uebelhack,, MD, PhD

    analyze & realize GmbH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 18, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

February 12, 2020

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)