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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Appetite Modulation (Focus of Study)
• Intervention / Treatment: Device: Placebo; Device: IQP-AK-102

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Udo Bongartz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit	Measured in kcal	4 weeks
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit	Measured in kcal	4 weeks
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms	Measured using VAS	4 weeks
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)	4 weeks
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	4 weeks
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)	4 weeks
Subjects global feeling of satiety		4 weeks
Food Craving Questionnaire	15 questions	4 weeks
Global evaluation of efficacy by the subjects and investigators		4 weeks
Global evaluation of safety by the subjects and investigators		4 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Udo Bongartz, MD, Analyze & Realize

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 19, 2014
• First Submitted That Met QC Criteria: January 19, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: INQ/009913