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

Phase 3CompletedNCT02041754

InQpharm Group40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Weight Loss Appetite Modulation (Focus of Study)

Interventions

IQP-AK-102DEVICE

PlaceboDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Udo Bongartz

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

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)

Time frame: 4 weeks

Secondary Outcomes

Difference in ad libitum energy intake between the two arms at baseline visit and at final visit

Measured in kcal

Time frame: 4 weeks

Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit

Measured in kcal

Time frame: 4 weeks

Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms

Measured using VAS

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 4 weeks

Data from ClinicalTrials.gov

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