Weight Loss
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTIQP-AK-102
IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Body Weight From Baseline to Week 12 | Baseline and 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Body Fat Content (%) From Baseline to Week 12 | Baseline and 12 weeks | 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). |
| Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | Baseline and 12 weeks | 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). |
| Food Craving Questionnaire (FCQ) | Baseline and 4, 8, and 12 weeks | 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. |
| Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | Baseline and 12 weeks | 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). |
| 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 | — |
| Global Evaluation of Efficacy by the Investigators | 12 weeks | — |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IQP-AK-102 2 capsules per dose, three times daily
IQP-AK-102 | 57 |
| Placebo 2 capsules per dose, 3 times daily
Placebo | 54 |
| Total | 111 |
Baseline characteristics
| Characteristic | Placebo | IQP-AK-102 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 57 Participants | 111 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 10.5 | 47.9 years STANDARD_DEVIATION 12.3 | 47.4 years STANDARD_DEVIATION 11.4 |
| Body Mass Index (BMI) | 29.0 kilogram per metre square (kg/m^2) STANDARD_DEVIATION 2.1 | 29.3 kilogram per metre square (kg/m^2) STANDARD_DEVIATION 2.7 | 29.2 kilogram per metre square (kg/m^2) STANDARD_DEVIATION 2.4 |
| Diastolic Blood Pressure | 81.3 mmHg STANDARD_DEVIATION 9.4 | 79.7 mmHg STANDARD_DEVIATION 6.2 | 80.5 mmHg STANDARD_DEVIATION 7.9 |
| Heart Rate | 70.7 Beats per minute STANDARD_DEVIATION 5.5 | 70.6 Beats per minute STANDARD_DEVIATION 5.3 | 70.6 Beats per minute STANDARD_DEVIATION 5.4 |
| Height | 168.2 centimetres (cm) STANDARD_DEVIATION 9 | 169.3 centimetres (cm) STANDARD_DEVIATION 9.6 | 168.8 centimetres (cm) STANDARD_DEVIATION 9.3 |
| Hip Circumference | 108.7 centimetres (cm) STANDARD_DEVIATION 7.8 | 110.2 centimetres (cm) STANDARD_DEVIATION 8.3 | 109.5 centimetres (cm) STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized Caucasian | 54 participants | 57 participants | 111 participants |
| Region of Enrollment Germany | 54 participants | 57 participants | 111 participants |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 83 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 28 Participants |
| Systolic Blood Pressure | 128.1 mmHg STANDARD_DEVIATION 15.7 | 123.9 mmHg STANDARD_DEVIATION 9.2 | 125.9 mmHg STANDARD_DEVIATION 12.9 |
| Waist Circumference | 98.5 centimetres (cm) STANDARD_DEVIATION 6.9 | 102.1 centimetres (cm) STANDARD_DEVIATION 10.8 | 100.4 centimetres (cm) STANDARD_DEVIATION 9.2 |
| Weight | 80.8 kilogram (kg) STANDARD_DEVIATION 8.8 | 83.0 kilogram (kg) STANDARD_DEVIATION 12.4 | 81.9 kilogram (kg) STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 58 | 12 / 56 |
| serious Total, serious adverse events | 1 / 58 | 0 / 56 |
Outcome results
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).
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-AK-102 | Mean Change in Body Weight From Baseline to Week 12 | 3.53 kilogram (kg) | Standard Deviation 2.28 |
| Placebo | Mean Change in Body Weight From Baseline to Week 12 | 0.14 kilogram (kg) | Standard Deviation 1.84 |
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: 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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-AK-102 | Food Craving Questionnaire (FCQ) | Baseline | 2.65 Units on a scale | Standard Deviation 1.28 |
| IQP-AK-102 | Food Craving Questionnaire (FCQ) | Week 4 | 2.17 Units on a scale | Standard Deviation 0.94 |
| IQP-AK-102 | Food Craving Questionnaire (FCQ) | Week 8 | 1.98 Units on a scale | Standard Deviation 0.96 |
| IQP-AK-102 | Food Craving Questionnaire (FCQ) | Week 12 | 2.31 Units on a scale | Standard Deviation 1.08 |
| Placebo | Food Craving Questionnaire (FCQ) | Week 12 | 2.47 Units on a scale | Standard Deviation 1.06 |
| Placebo | Food Craving Questionnaire (FCQ) | Baseline | 2.74 Units on a scale | Standard Deviation 1.07 |
| Placebo | Food Craving Questionnaire (FCQ) | Week 8 | 2.34 Units on a scale | Standard Deviation 0.92 |
| Placebo | Food Craving Questionnaire (FCQ) | Week 4 | 2.47 Units on a scale | Standard Deviation 1.04 |
Secondary
Global Evaluation of Efficacy by the Investigators
Time frame: 12 weeks
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-AK-102 | Global Evaluation of Efficacy by the Investigators | Very Good | 31 subjects |
| IQP-AK-102 | Global Evaluation of Efficacy by the Investigators | Good | 18 subjects |
| IQP-AK-102 | Global Evaluation of Efficacy by the Investigators | Moderate | 4 subjects |
| IQP-AK-102 | Global Evaluation of Efficacy by the Investigators | Poor | 0 subjects |
| Placebo | Global Evaluation of Efficacy by the Investigators | Poor | 19 subjects |
| Placebo | Global Evaluation of Efficacy by the Investigators | Very Good | 1 subjects |
| Placebo | Global Evaluation of Efficacy by the Investigators | Moderate | 19 subjects |
| Placebo | Global Evaluation of Efficacy by the Investigators | Good | 6 subjects |
Secondary
Global Evaluation of Efficacy by the Subjects
Time frame: 12 weeks
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-AK-102 | Global Evaluation of Efficacy by the Subjects | Very Good | 28 subjects |
| IQP-AK-102 | Global Evaluation of Efficacy by the Subjects | Good | 22 subjects |
| IQP-AK-102 | Global Evaluation of Efficacy by the Subjects | Moderate | 4 subjects |
| IQP-AK-102 | Global Evaluation of Efficacy by the Subjects | Poor | 0 subjects |
| Placebo | Global Evaluation of Efficacy by the Subjects | Poor | 15 subjects |
| Placebo | Global Evaluation of Efficacy by the Subjects | Very Good | 1 subjects |
| Placebo | Global Evaluation of Efficacy by the Subjects | Moderate | 22 subjects |
| Placebo | Global Evaluation of Efficacy by the Subjects | Good | 6 subjects |
Secondary
Global Evaluation of Safety by the Investigators
Time frame: 12 weeks
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-AK-102 | Global Evaluation of Safety by the Investigators | Very Good | 46 subjects |
| IQP-AK-102 | Global Evaluation of Safety by the Investigators | Good | 6 subjects |
| IQP-AK-102 | Global Evaluation of Safety by the Investigators | Moderate | 0 subjects |
| IQP-AK-102 | Global Evaluation of Safety by the Investigators | Poor | 0 subjects |
| Placebo | Global Evaluation of Safety by the Investigators | Poor | 0 subjects |
| Placebo | Global Evaluation of Safety by the Investigators | Very Good | 35 subjects |
| Placebo | Global Evaluation of Safety by the Investigators | Moderate | 1 subjects |
| Placebo | Global Evaluation of Safety by the Investigators | Good | 7 subjects |
Secondary
Global Evaluation of Safety by the Subjects
Time frame: 12 weeks
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-AK-102 | Global Evaluation of Safety by the Subjects | Very Good | 46 subjects |
| IQP-AK-102 | Global Evaluation of Safety by the Subjects | Good | 7 subjects |
| IQP-AK-102 | Global Evaluation of Safety by the Subjects | Moderate | 0 subjects |
| IQP-AK-102 | Global Evaluation of Safety by the Subjects | Poor | 0 subjects |
| Placebo | Global Evaluation of Safety by the Subjects | Poor | 0 subjects |
| Placebo | Global Evaluation of Safety by the Subjects | Very Good | 37 subjects |
| Placebo | Global Evaluation of Safety by the Subjects | Moderate | 1 subjects |
| Placebo | Global Evaluation of Safety by the Subjects | Good | 7 subjects |
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).
Time frame: Baseline and 12 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-AK-102 | Mean Change in Body Fat Content (%) From Baseline to Week 12 | 0.95 Percentage of body fat (%) | Standard Deviation 2.91 |
| Placebo | Mean Change in Body Fat Content (%) From Baseline to Week 12 | 0.08 Percentage of body fat (%) | Standard Deviation 1.9 |
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).
Time frame: Baseline and 12 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-AK-102 | Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | 1.32 kilogram (kg) | Standard Deviation 2.91 |
| Placebo | Mean Change in Body Fat Mass (kg) From Baseline to Week 12 | 0.05 kilogram (kg) | Standard Deviation 1.95 |
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).
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-AK-102 | Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | Waist Circumference | 2.12 centimetre (cm) | Standard Deviation 2.99 |
| IQP-AK-102 | Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | Hip Circumference | 2.25 centimetre (cm) | Standard Deviation 2.41 |
| Placebo | Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | Waist Circumference | 0.92 centimetre (cm) | Standard Deviation 3.24 |
| Placebo | Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 | Hip Circumference | 1.07 centimetre (cm) | Standard Deviation 1.2 |