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

NCT ID: NCT02041754

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Weight Loss Appetite Modulation (Focus of Study)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

IQP-AK-102

Intervention Type DEVICE

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Interventions

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IQP-AK-102

Intervention Type DEVICE

Placebo

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InQpharm Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Udo Bongartz, MD

Role: PRINCIPAL_INVESTIGATOR

Analyze & Realize

Locations

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Udo Bongartz

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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INQ/009913

Identifier Type: -

Identifier Source: org_study_id

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