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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041754
• Other study ID #: INQ/009913
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2014
• Last updated: March 24, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

Not available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appetite Modulation (Focus of Study)
• Weight Loss

Intervention

Device:
• IQP-AK-102

• Placebo

Locations

Country	Name	City	State
Germany	Udo Bongartz	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Difference in ad libitum energy intake between the two arms at baseline visit and at final visit	Measured in kcal	4 weeks	No
Secondary	Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit	Measured in kcal	4 weeks	No
Secondary	Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms	Measured using VAS	4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Subjects global feeling of satiety		4 weeks	No
Secondary	Food Craving Questionnaire	15 questions	4 weeks	No
Secondary	Global evaluation of efficacy by the subjects and investigators		4 weeks	No
Secondary	Global evaluation of safety by the subjects and investigators		4 weeks	Yes