Safety and Efficacy of IQP-AK-102 in Reducing Appetite
Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 19, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMarch 25, 2015
March 1, 2015
7 months
January 19, 2014
March 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
4 weeks
Secondary Outcomes (10)
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit
4 weeks
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit
4 weeks
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms
4 weeks
Difference in the mean change in body weight between the 2 arms, from baseline to the final visit
4 weeks
Changes in waist and hip circumference
4 weeks
- +5 more secondary outcomes
Study Arms (2)
IQP-AK-102
ACTIVE COMPARATOR2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
Placebo
PLACEBO COMPARATOR2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years
- ≤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
You may not qualify if:
- Known sensitivity to the ingredients of the device
- Presence of any active gastrointestinal disease
- Malabsorption disorders
- Pancreatitis
- Stenosis in the GI tract
- Bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
Udo Bongartz
Berlin, State of Berlin, 10369, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Udo Bongartz, MD
Analyze & Realize
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2014
First Posted
January 22, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 25, 2015
Record last verified: 2015-03