A Phase 3 interventional study of IQP-AK-102 and Placebo in Weight Loss, sponsored by InQpharm Group. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by InQpharm Group · Phase 3, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.
This study's enrollment of 119 is above the median of 73 across 1,540 interventional studies indexed under Weight Loss.
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Exclusion Criteria:
2 capsules per dose, three times daily
Dietary Supplement: IQP-AK-102
2 capsules per dose, 3 times daily
Dietary Supplement: Placebo
IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.
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.
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).
Time frame: Baseline and 12 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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: 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
Global Evaluation of Efficacy by the Investigators
Time frame: 12 weeks
Global Evaluation of Efficacy by the Subjects
Time frame: 12 weeks
Global Evaluation of Safety by the Investigators
Time frame: 12 weeks
Global Evaluation of Safety by the Subjects
Time frame: 12 weeks
| Milestone | IQP-AK-102 | Placebo |
|---|---|---|
| Started | 60 | 59 |
| Intention-to-treat population | 57 | 54 |
| Completed | 54 | 48 |
| Not completed | 6 | 11 |
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).
| kilogram (kg) | IQP-AK-102 | Placebo |
|---|---|---|
| Mean Change in Body Weight From Baseline to Week 12 | 3.53 ± 2.28 | 0.14 ± 1.84 |
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).
| centimetre (cm) | IQP-AK-102 | Placebo |
|---|---|---|
| Waist Circumference | 2.12 ± 2.99 | 0.92 ± 3.24 |
| Hip Circumference | 2.25 ± 2.41 | 1.07 ± 1.20 |
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).
| Percentage of body fat (%) | IQP-AK-102 | Placebo |
|---|---|---|
| Mean Change in Body Fat Content (%) From Baseline to Week 12 | 0.95 ± 2.91 | 0.08 ± 1.90 |
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).
| kilogram (kg) | IQP-AK-102 | Placebo |
|---|---|---|
| Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | 1.32 ± 2.91 | 0.05 ± 1.95 |
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.
| Units on a scale | IQP-AK-102 | Placebo |
|---|---|---|
| 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 |
| subjects | IQP-AK-102 | Placebo |
|---|---|---|
| Very Good | 31 | 1 |
| Good | 18 | 6 |
| Moderate | 4 | 19 |
| Poor | 0 | 19 |
| subjects | IQP-AK-102 | Placebo |
|---|---|---|
| Very Good | 28 | 1 |
| Good | 22 | 6 |
| Moderate | 4 | 22 |
| Poor | 0 | 15 |
| subjects | IQP-AK-102 | Placebo |
|---|---|---|
| Very Good | 46 | 35 |
| Good | 6 | 7 |
| Moderate | 0 | 1 |
| Poor | 0 | 0 |
| subjects | IQP-AK-102 | Placebo |
|---|---|---|
| Very Good | 46 | 37 |
| Good | 7 | 7 |
| Moderate | 0 | 1 |
| Poor | 0 | 0 |
Collected over During the treatment period ie. 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IQP-AK-102 | — | 1/58 (1.7%) | 12/58 (20.7%) |
| Placebo | — | 0/56 (0%) | 12/56 (21.4%) |
| Event | IQP-AK-102 | Placebo |
|---|---|---|
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/58 | 0/56 |
| Event | IQP-AK-102 | Placebo |
|---|---|---|
| Common cold or upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 6/58 | 3/56 |
| Toothache or dental extractionGeneral disorders | 0/58 | 2/56 |
| Headaches and MigraineGeneral disorders | 1/58 | 2/56 |
| Nausea & VomitingGastrointestinal disorders | 2/58 | 0/56 |
| Gastrointestinal complaintsGastrointestinal disorders | 0/58 | 1/56 |
| Distortion and contusion of kneeGeneral disorders | 1/58 | 1/56 |
| Acute Sciatica (Dorsalgia)Nervous system disorders | 0/58 | 1/56 |
| Macular degenerationEye disorders | 0/58 | 1/56 |
| Infection of urinary tractRenal and urinary disorders | 0/58 | 1/56 |
| Allergic RhinitisRespiratory, thoracic and mediastinal disorders | 1/58 | 0/56 |
| Age, Categorical(Participants) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 57 | 54 | 111 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Mean | 47.9 ± 12.3 | 46.3 ± 10.5 | 47.4 ± 11.4 |
| Sex: Female, Male(Participants) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Female | 40 | 43 | 83 |
| Male | 17 | 11 | 28 |
| Race/Ethnicity, Customized(participants) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Caucasian | 57 | 54 | 111 |
| Region of Enrollment(participants) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Germany | 57 | 54 | 111 |
| Height(centimetres (cm)) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Mean | 169.3 ± 9.6 | 168.2 ± 9.0 | 168.8 ± 9.3 |
| Weight(kilogram (kg)) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Mean | 83.0 ± 12.4 | 80.8 ± 8.8 | 81.9 ± 10.8 |
| Body Mass Index (BMI)(kilogram per metre square (kg/m^2)) | IQP-AK-102 | Placebo | Total |
|---|---|---|---|
| Mean | 29.3 ± 2.7 | 29.0 ± 2.1 | 29.2 ± 2.4 |
5 further baseline measures are reported on the registry.
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