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Safety and Efficacy of IQP-AK-102 in Reducing Appetite

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ClinicalTrials.gov Identifier: NCT02041754
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Tracking Information
First Submitted Date  ICMJE January 19, 2014
First Posted Date  ICMJE January 22, 2014
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2014)
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit [ Time Frame: 4 weeks ]
Measured using a visual analogue scale (VAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2014)
  • Difference in ad libitum energy intake between the two arms at baseline visit and at final visit [ Time Frame: 4 weeks ]
    Measured in kcal
  • Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit [ Time Frame: 4 weeks ]
    Measured in kcal
  • Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms [ Time Frame: 4 weeks ]
    Measured using VAS
  • Difference in the mean change in body weight between the 2 arms, from baseline to the final visit [ Time Frame: 4 weeks ]
    Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA)
  • Changes in waist and hip circumference [ Time Frame: 4 weeks ]
    Measured in cm. Waist: measured at the level midway between the lateral lower rib margin and the iliac crest Hip: measured as the maximal circumference over the buttocks
  • Changes in body fat content and fat free mass [ Time Frame: 4 weeks ]
    Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA)
  • Subjects global feeling of satiety [ Time Frame: 4 weeks ]
  • Food Craving Questionnaire [ Time Frame: 4 weeks ]
    15 questions
  • Global evaluation of efficacy by the subjects and investigators [ Time Frame: 4 weeks ]
  • Global evaluation of safety by the subjects and investigators [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of IQP-AK-102 in Reducing Appetite
Official Title  ICMJE Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects
Brief Summary The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Weight Loss
  • Appetite Modulation (Focus of Study)
Intervention  ICMJE
  • Device: IQP-AK-102
  • Device: Placebo
Study Arms  ICMJE
  • Active Comparator: IQP-AK-102
    2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
    Intervention: Device: IQP-AK-102
  • Placebo Comparator: Placebo
    2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
    Intervention: Device: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 65 years
  • 25≤BMI≤35
  • Expressed desire for weight loss
  • Accustomed to 3 main meals/day
  • Generally in good health
  • Consistent and stable body weight 3 months prior to study enrolment
  • Consistent regular physical activity
  • Commitment to avoid the use of other weight loss products during study
  • Commitment to adhere to diet and lifestyle recommended for the study

Exclusion Criteria:

  • Known sensitivity to the ingredients of the device
  • Presence of any active gastrointestinal disease
  • Malabsorption disorders
  • Pancreatitis
  • Stenosis in the GI tract
  • Bariatric surgery
  • Any other reason deemed suitable for exclusion, per investigator's judgement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02041754
Other Study ID Numbers  ICMJE INQ/009913
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InQpharm Group
Study Sponsor  ICMJE InQpharm Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Udo Bongartz, MD Analyze & Realize
PRS Account InQpharm Group
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP