Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Weight Loss Appetite Modulation (Focus of Study) Device: IQP-AK-102 Device: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
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
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
Device: Placebo



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Difference in ad libitum energy intake between the two arms at baseline visit and at final visit [ Time Frame: 4 weeks ]
    Measured in kcal

  2. 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

  3. Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms [ Time Frame: 4 weeks ]
    Measured using VAS

  4. 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)

  5. 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

  6. 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)

  7. Subjects global feeling of satiety [ Time Frame: 4 weeks ]
  8. Food Craving Questionnaire [ Time Frame: 4 weeks ]
    15 questions

  9. Global evaluation of efficacy by the subjects and investigators [ Time Frame: 4 weeks ]
  10. Global evaluation of safety by the subjects and investigators [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041754


Locations
Layout table for location information
Germany
Udo Bongartz
Berlin, Germany, 10369
Sponsors and Collaborators
InQpharm Group
Investigators
Layout table for investigator information
Principal Investigator: Udo Bongartz, MD Analyze & Realize

Layout table for additonal information
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT02041754    
Other Study ID Numbers: INQ/009913
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms