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

Phase 3

Completed

• Conditions: Weight Loss; Appetite Modulation (Focus of Study)
• Interventions: Device: IQP-AK-102; Device: Placebo

• Registration Number: NCT02041754
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-19
• Study First Posted: 2014-01-22
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IQP-AK-102	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
Placebo	Placebo	2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water

Primary Outcome Measures

Name	Time	Method
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit	4 weeks	Measured using a visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit	4 weeks	Measured in kcal
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit	4 weeks	Measured in kcal
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms	4 weeks	Measured using VAS
Difference in the mean change in body weight between the 2 arms, from baseline to the final visit	4 weeks	Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA)
Changes in waist and hip circumference	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
Changes in body fat content and fat free mass	4 weeks	Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA)
Subjects global feeling of satiety	4 weeks
Food Craving Questionnaire	4 weeks	15 questions
Global evaluation of efficacy by the subjects and investigators	4 weeks
Global evaluation of safety by the subjects and investigators	4 weeks

Trial Locations

Locations (1)

Udo Bongartz; 🇩🇪 Berlin, Germany