Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by biological, behavioral and environmental stimuli. Satiation (intrameal satiety) is defined as the process of feeling full and subsequently stopping food consumption during eating, it therefore reduces hunger and limits the energy consumptions during meals. On the other hand, satiety or more precisely intermeal satiety, delays the onset and possibly reduces the consumption of the next meal. High viscosity and bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than macronutrients or clear liquid.
Due to its unique physicochemical properties, dietary fibre has been recognized as a potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake, and eventually leading on to weight loss.
The investigational product is formulated from IQP-AK-102, a proprietary, patent pending combination of three soluble fibres. In-vitro studies showed synergistic properties for the fibres in IQP-AK-102. When consumed orally, IQP-AK-102 capsules dissolve in the stomach to release the fibres. Once hydrated, the fibres swell to form a thick, viscous and indigestible gel structure in the stomach. This physical structure results in increased gastric distension and delays the gastric emptying that induces satiety and fullness.
However the unique composition of IQP-AK-102 had not been evaluated in human clinical studies. The objective of this placebo controlled, double blind study was to confirm the benefit of IQP-AK-102 in weight loss through promoting satiety and managing appetite. In this study, 120 overweight and obese subjects (60 per study arm) were tested to investigate if IQP-AK-102 is effective in reducing body weight over a period of 12 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-AK-102 | Active Comparator | 2 capsules per dose, three times daily |
|
| Placebo | Placebo Comparator | 2 capsules per dose, 3 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Udo Bongartz | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube | Berlin | State of Berlin | 10709 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IQP-AK-102 | 2 capsules per dose, three times daily IQP-AK-102 |
| FG001 | Placebo | 2 capsules per dose, 3 times daily Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IQP-AK-102 | 2 capsules per dose, three times daily IQP-AK-102 |
| BG001 | Placebo | 2 capsules per dose, 3 times daily Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline and 12 weeks |
|
During the treatment period ie. 12 weeks.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IQP-AK-102 | 2 capsules per dose, three times daily IQP-AK-102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Improbable relation to Investigational product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold or upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Light to moderate |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pee-Win Chong | InQpharm Europe Ltd | +603 6201 9690 | 358 | pwchong@inqpharm.com |
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Baseline and 12 weeks |
| Mean Change in Body Fat Content (%) From Baseline to Week 12 | 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). | Baseline and 12 weeks |
| Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | 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). | Baseline and 12 weeks |
| Food Craving Questionnaire (FCQ) | 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:
Results were expressed as the mean score for the whole population in the respective intervention group. | Baseline and 4, 8, and 12 weeks |
| Global Evaluation of Efficacy by the Investigators | 12 weeks |
| Global Evaluation of Efficacy by the Subjects | 12 weeks |
| Global Evaluation of Safety by the Investigators | 12 weeks |
| Global Evaluation of Safety by the Subjects | 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimetres (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per metre square (kg/m^2) |
|
| Waist Circumference | Mean | Standard Deviation | centimetres (cm) |
|
| Hip Circumference | Mean | Standard Deviation | centimetres (cm) |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Mean | Standard Deviation | Beats per minute |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | 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). | Posted | Mean | Standard Deviation | centimetre (cm) | Baseline and 12 weeks |
|
|
|
| Secondary | Mean Change in Body Fat Content (%) From Baseline to Week 12 | 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). | 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. | Posted | Mean | Standard Deviation | Percentage of body fat (%) | Baseline and 12 weeks |
|
|
|
| Secondary | Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | 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). | 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. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline and 12 weeks |
|
|
|
| Secondary | Food Craving Questionnaire (FCQ) | 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:
Results were expressed as the mean score for the whole population in the respective intervention group. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4, 8, and 12 weeks |
|
|
|
| Secondary | Global Evaluation of Efficacy by the Investigators | 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. | Posted | Number | subjects | 12 weeks |
|
|
|
| Secondary | Global Evaluation of Efficacy by the Subjects | 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. | Posted | Number | subjects | 12 weeks |
|
|
|
| Secondary | Global Evaluation of Safety by the Investigators | 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. | Posted | Number | subjects | 12 weeks |
|
|
|
| Secondary | Global Evaluation of Safety by the Subjects | 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. | Posted | Number | subjects | 12 weeks |
|
|
|
| 1 |
| 58 |
| 12 |
| 58 |
| EG001 | Placebo | 2 capsules per dose, 3 times daily Placebo | 0 | 56 | 12 | 56 |
|
|
| Toothache or dental extraction | General disorders | Non-systematic Assessment |
|
| Gastrointestinal complaints | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headaches and Migraine | General disorders | Non-systematic Assessment |
|
| Distortion and contusion of knee | General disorders | Non-systematic Assessment |
|
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abcess of the skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | In the breastbone area |
|
| Acute Sciatica (Dorsalgia) | Nervous system disorders | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | Non-systematic Assessment |
|
| Infection of urinary tract | Renal and urinary disorders | Non-systematic Assessment |
|
| Nausea & Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Week 8 |
|
| Week 12 |
|
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|