Appetite Modulation (Focus of Study), Weight Loss
Conditions
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.
Interventions
DEVICEIQP-AK-102
DEVICEPlacebo
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Difference in ad libitum energy intake between the two arms at baseline visit and at final visit | 4 weeks | Measured in kcal |
| 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 | — |
| 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) |
Countries
Germany
Outcome results
None listed