Weight LossPhase 3NCT01905956
Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
A Phase 3 study testing IQP-AK-102 in people with Weight Loss, run by InQpharm Group at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- IQP-AK-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of IQP- AK-102 in Reducing Body Weight in Overweight and Obese Subjects
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.
Read the 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.
- Conditions
- Weight Loss
- Being tested
- IQP-AK-102, Placebo
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-AK-102Dietary supplement
IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| IQP-AK-102 | Active comparator | 2 capsules per dose, three times daily Receives: Dietary Supplement: IQP-AK-102 |
| Placebo | Placebo comparator | 2 capsules per dose, 3 times daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 weeks
Secondary outcomes (8)
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).
Measured: 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).
Measured: 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).
Measured: 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:
- = I do not agree at all
- = I do not agree
- = Neutral
- = I agree
- = I highly agree
Results were expressed as the mean score for the whole population in the respective intervention group.
Measured: Baseline and 4, 8, and 12 weeks
Global Evaluation of Efficacy by the Investigators
Measured: 12 weeks
Global Evaluation of Efficacy by the Subjects
Measured: 12 weeks
Global Evaluation of Safety by the Investigators
Measured: 12 weeks
Global Evaluation of Safety by the Subjects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Udo Bongartz, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905956
- Sponsor's protocol ID
- INQ/010013
- Status last verified
- Mar 2015
- First submitted
- 19 Jul 2013
- Last updated
- 8 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of IQP- AK-102 in Reducing Body Weight in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT01905956
- Acronym / sponsor ID
- INQ/010013
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 8 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQP-AK-102 | Active comparator | Dietary Supplement: IQP-AK-1022 capsules per dose, three times daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules per dose, 3 times daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 65 years
- 25≤BMI≤35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Generally in good health
Key exclusion criteria (7 listed)
- Known sensitivity to the ingredients of the device
- Presence of any active gastrointestinal disease
- Malabsorption disorders
- Pancreatitis
- Stenosis in the GI tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQP-AK-102IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients. | Dietary supplement | IQP-AK-102 |
| PlaceboThe placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity. | Dietary supplement | Placebo |
Primary outcome
Mean Change in Body Weight From Baseline to Week 12
Time frame: 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).
8 secondary outcomes
Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12
Time frame: Baseline and 12 weeks
Mean Change in Body Fat Content (%) From Baseline to Week 12
Time frame: Baseline and 12 weeks
Mean Change in Body Fat Mass (kg) From Baseline to Week 12
Time frame: Baseline and 12 weeks
Food Craving Questionnaire (FCQ)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udo Bongartz principal investigator
analyze & realize GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IQP-AK-102 in people with Weight Loss, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Body Weight From Baseline to Week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.