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

InQpharm

Status and phase: Completed; Phase 3

Conditions: Weight Loss; Appetite Modulation (Focus of Study)

Treatments: Device: Placebo; Device: IQP-AK-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT02041754

INQ/009913

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

IQP-AK-102

Active Comparator group

Description:

2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water

Treatment:

Device: IQP-AK-102

Placebo

Placebo Comparator group

Description:

2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water

Treatment:

Device: Placebo