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

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ClinicalTrials.gov Identifier: NCT01905956
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Weight Loss
Interventions Dietary Supplement: IQP-AK-102
Dietary Supplement: Placebo
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Period Title: Overall Study
Started 60 [1] 59 [1]
Intention-to-treat Population 57 [2] 54 [2]
Completed 54 [3] 48 [3]
Not Completed 6 11
[1]
Randomized
[2]
Intention-to-treat population
[3]
Per-protocol population
Arm/Group Title IQP-AK-102 Placebo Total
Hide Arm/Group Description

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 57 54 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
57
 100.0%
54
 100.0%
111
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 54 participants 111 participants
47.9  (12.3) 46.3  (10.5) 47.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Female
40
  70.2%
43
  79.6%
83
  74.8%
Male
17
  29.8%
11
  20.4%
28
  25.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 57 participants 54 participants 111 participants
57 54 111
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 57 participants 54 participants 111 participants
57 54 111
Height  
Mean (Standard Deviation)
Unit of measure:  Centimetres (cm)
Number Analyzed 57 participants 54 participants 111 participants
169.3  (9.6) 168.2  (9.0) 168.8  (9.3)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 57 participants 54 participants 111 participants
83.0  (12.4) 80.8  (8.8) 81.9  (10.8)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per metre square (kg/m^2)
Number Analyzed 57 participants 54 participants 111 participants
29.3  (2.7) 29.0  (2.1) 29.2  (2.4)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimetres (cm)
Number Analyzed 57 participants 54 participants 111 participants
102.1  (10.8) 98.5  (6.9) 100.4  (9.2)
Hip Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimetres (cm)
Number Analyzed 57 participants 54 participants 111 participants
110.2  (8.3) 108.7  (7.8) 109.5  (8.1)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 57 participants 54 participants 111 participants
123.9  (9.2) 128.1  (15.7) 125.9  (12.9)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 57 participants 54 participants 111 participants
79.7  (6.2) 81.3  (9.4) 80.5  (7.9)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 57 participants 54 participants 111 participants
70.6  (5.3) 70.7  (5.5) 70.6  (5.4)
1.Primary Outcome
Title Mean Change in Body Weight From Baseline to Week 12
Hide Description

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).

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: kilogram (kg)
3.53  (2.28) 0.14  (1.84)
2.Secondary Outcome
Title Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12
Hide Description

Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.

Hip circumference (cm) was measured as the maximal circumference over the buttocks.

Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values).

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: centimetre (cm)
Waist Circumference 2.12  (2.99) 0.92  (3.24)
Hip Circumference 2.25  (2.41) 1.07  (1.20)
3.Secondary Outcome
Title Mean Change in Body Fat Content (%) From Baseline to Week 12
Hide Description

Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).

Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values).

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 57 53
Mean (Standard Deviation)
Unit of Measure: Percentage of body fat (%)
0.95  (2.91) 0.08  (1.90)
4.Secondary Outcome
Title Mean Change in Body Fat Mass (kg) From Baseline to Week 12
Hide Description

Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).

Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values).

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 57 53
Mean (Standard Deviation)
Unit of Measure: kilogram (kg)
1.32  (2.91) 0.05  (1.95)
5.Secondary Outcome
Title Food Craving Questionnaire (FCQ)
Hide Description

This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:

  1. = I do not agree at all
  2. = I do not agree
  3. = Neutral
  4. = I agree
  5. = I highly agree

Results were expressed as the mean score for the whole population in the respective intervention group.

Time Frame Baseline and 4, 8, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 52 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.65  (1.28) 2.74  (1.07)
Week 4 2.17  (0.94) 2.47  (1.04)
Week 8 1.98  (0.96) 2.34  (0.92)
Week 12 2.31  (1.08) 2.47  (1.06)
6.Secondary Outcome
Title Global Evaluation of Efficacy by the Investigators
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 53 45
Measure Type: Number
Unit of Measure: subjects
Very Good 31 1
Good 18 6
Moderate 4 19
Poor 0 19
7.Secondary Outcome
Title Global Evaluation of Efficacy by the Subjects
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 54 44
Measure Type: Number
Unit of Measure: subjects
Very Good 28 1
Good 22 6
Moderate 4 22
Poor 0 15
8.Secondary Outcome
Title Global Evaluation of Safety by the Investigators
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 52 43
Measure Type: Number
Unit of Measure: subjects
Very Good 46 35
Good 6 7
Moderate 0 1
Poor 0 0
9.Secondary Outcome
Title Global Evaluation of Safety by the Subjects
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description:

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

Overall Number of Participants Analyzed 53 45
Measure Type: Number
Unit of Measure: subjects
Very Good 46 37
Good 7 7
Moderate 0 1
Poor 0 0
Time Frame During the treatment period ie. 12 weeks.
Adverse Event Reporting Description

The causality of the AEs and intake of IP was assessed by the clinician.

Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.

 
Arm/Group Title IQP-AK-102 Placebo
Hide Arm/Group Description

2 capsules per dose, three times daily

IQP-AK-102

2 capsules per dose, 3 times daily

Placebo

All-Cause Mortality
IQP-AK-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
IQP-AK-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/58 (1.72%)      0/56 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate Cancer * [1]  1/58 (1.72%)  0/56 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Improbable relation to Investigational product
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IQP-AK-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/58 (20.69%)      12/56 (21.43%)    
Eye disorders     
Macular degeneration *  0/58 (0.00%)  0 1/56 (1.79%)  1
Gastrointestinal disorders     
Gastrointestinal complaints *  0/58 (0.00%)  0 1/56 (1.79%)  1
Nausea & Vomiting *  2/58 (3.45%)  2 0/56 (0.00%)  0
Flatulence *  1/58 (1.72%)  1 0/56 (0.00%)  0
Constipation *  1/58 (1.72%)  1 0/56 (0.00%)  0
General disorders     
Toothache or dental extraction *  0/58 (0.00%)  0 2/56 (3.57%)  3
Headaches and Migraine *  1/58 (1.72%)  1 2/56 (3.57%)  2
Distortion and contusion of knee *  1/58 (1.72%)  1 1/56 (1.79%)  1
Nervous system disorders     
Acute Sciatica (Dorsalgia) *  0/58 (0.00%)  0 1/56 (1.79%)  1
Renal and urinary disorders     
Infection of urinary tract *  0/58 (0.00%)  0 1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders     
Common cold or upper respiratory tract infection * [1]  6/58 (10.34%)  6 3/56 (5.36%)  4
Allergic Rhinitis *  1/58 (1.72%)  1 0/56 (0.00%)  0
Skin and subcutaneous tissue disorders     
Abcess of the skin * [2]  1/58 (1.72%)  1 0/56 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Light to moderate
[2]
In the breastbone area
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pee-Win Chong
Organization: InQpharm Europe Ltd
Phone: +603 6201 9690 ext 358
EMail: pwchong@inqpharm.com
Layout table for additonal information
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01905956    
Other Study ID Numbers: INQ/010013
First Submitted: July 19, 2013
First Posted: July 23, 2013
Results First Submitted: January 4, 2016
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016