Back to resultsSafety and Efficacy of IQP-AK-102 in Reducing Appetite
Primary Purpose
Weight Loss, Appetite Modulation (Focus of Study)
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
IQP-AK-102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility 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
Sites / Locations
- Udo Bongartz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IQP-AK-102
Placebo
Arm Description
2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
Outcomes
Primary Outcome Measures
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
Measured using a visual analogue scale (VAS)
Secondary Outcome Measures
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit
Measured in kcal
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit
Measured in kcal
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms
Measured using VAS
Difference in the mean change in body weight between the 2 arms, from baseline to the final visit
Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA)
Changes in waist and hip circumference
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
Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA)
Subjects global feeling of satiety
Food Craving Questionnaire
15 questions
Global evaluation of efficacy by the subjects and investigators
Global evaluation of safety by the subjects and investigators
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02041754
Brief Title
Safety and Efficacy of IQP-AK-102 in Reducing Appetite
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Appetite Modulation (Focus of Study)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IQP-AK-102
Arm Type
Active Comparator
Arm Description
2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
Intervention Type
Device
Intervention Name(s)
IQP-AK-102
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
Description
Measured using a visual analogue scale (VAS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit
Description
Measured in kcal
Time Frame
4 weeks
Title
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit
Description
Measured in kcal
Time Frame
4 weeks
Title
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms
Description
Measured using VAS
Time Frame
4 weeks
Title
Difference in the mean change in body weight between the 2 arms, from baseline to the final visit
Description
Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA)
Time Frame
4 weeks
Title
Changes in waist and hip circumference
Description
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
Time Frame
4 weeks
Title
Changes in body fat content and fat free mass
Description
Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA)
Time Frame
4 weeks
Title
Subjects global feeling of satiety
Time Frame
4 weeks
Title
Food Craving Questionnaire
Description
15 questions
Time Frame
4 weeks
Title
Global evaluation of efficacy by the subjects and investigators
Time Frame
4 weeks
Title
Global evaluation of safety by the subjects and investigators
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udo Bongartz, MD
Organizational Affiliation
Analyze & Realize
Official's Role
Principal Investigator
Facility Information:
Facility Name
Udo Bongartz
City
Berlin
ZIP/Postal Code
10369
Country
Germany
12. IPD Sharing Statement
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Safety and Efficacy of IQP-AK-102 in Reducing Appetite
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