Safety and Efficacy of IQP- AK-102 in Reducing Body Weight

NCT01905956 | Completed Phase 3 Results

• 1 other identifier: INQ/010013
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Mean Change in Body Weight From Baseline to Week 12

  Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values).

  Baseline and 12 weeks

Secondary Outcomes (8)

• Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12

  Baseline and 12 weeks

• Mean Change in Body Fat Content (%) From Baseline to Week 12

  Baseline and 12 weeks

• Mean Change in Body Fat Mass (kg) From Baseline to Week 12

  Baseline and 12 weeks

• Food Craving Questionnaire (FCQ)

  Baseline and 4, 8, and 12 weeks

• Global Evaluation of Efficacy by the Investigators

  12 weeks

Study Arms (2)

IQP-AK-102

ACTIVE COMPARATOR

2 capsules per dose, three times daily

Dietary Supplement: IQP-AK-102

Placebo

PLACEBO COMPARATOR

2 capsules per dose, 3 times daily

Dietary Supplement: Placebo

Interventions

IQP-AK-102 DIETARY_SUPPLEMENT

IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.

IQP-AK-102

Placebo DIETARY_SUPPLEMENT

The placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years
• ≤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

You may not qualify if:

• Known sensitivity to the ingredients of the device
• Presence of any active gastrointestinal disease
• Malabsorption disorders
• Pancreatitis
• Stenosis in the GI tract
• Bariatric surgery

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Barbara Grube

Berlin, State of Berlin, 10709, Germany

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pee-Win Chong
• Organization: InQpharm Europe Ltd

pwchong@inqpharm.com

+603 6201 9690

Study Officials

• Udo Bongartz

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 8, 2016
• Results First Posted: March 8, 2016

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)