Weight LossPhase 3NCT02041754
Safety and Efficacy of IQP-AK-102 in Reducing Appetite
A Phase 3 study testing IQP-AK-102 in people with Weight Loss and Appetite Modulation (Focus of Study), 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, aiming to reduce the appetite. 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, Appetite Modulation (Focus of Study)
- What is being tested?
- IQP-AK-102
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy 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, aiming to reduce the appetite.
- Conditions
- Weight Loss, Appetite Modulation (Focus of Study)
- 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-102Device
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| IQP-AK-102 | Active comparator | 2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water Receives: Device: IQP-AK-102 |
| Placebo | Placebo comparator | 2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
Measured using a visual analogue scale (VAS)
Measured: 4 weeks
Secondary outcomes (10)
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit
Measured in kcal
Measured: 4 weeks
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit
Measured in kcal
Measured: 4 weeks
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms
Measured using VAS
Measured: 4 weeks
Difference in the mean change in body weight between the 2 arms, from baseline to the final visit
Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA)
Measured: 4 weeks
Changes in waist and hip circumference
Measured in cm. Waist: measured at the level midway between the lateral lower rib margin and the iliac crest Hip: measured as the maximal circumference over the buttocks
Measured: 4 weeks
Changes in body fat content and fat free mass
Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA)
Measured: 4 weeks
Subjects global feeling of satiety
Measured: 4 weeks
Food Craving Questionnaire
15 questions
Measured: 4 weeks
Global evaluation of efficacy by the subjects and investigators
Measured: 4 weeks
Global evaluation of safety by the subjects and investigators
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Udo Bongartz, MD, Principal investigator, Analyze & Realize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041754
- Sponsor's protocol ID
- INQ/009913
- Status last verified
- Mar 2015
- First submitted
- 19 Jan 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02041754
- Acronym / sponsor ID
- INQ/009913
- Conditions
- Weight Loss, Appetite Modulation (Focus of Study)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
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, aiming to reduce the appetite.
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 | Device: IQP-AK-1022 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water |
| Placebo | Placebo comparator | Device: Placebo2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water |
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-102 | Device | IQP-AK-102 |
| Placebo | Device | Placebo |
Primary outcome
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
Time frame: 4 weeks
Measured using a visual analogue scale (VAS)
10 secondary outcomes
Difference in ad libitum energy intake between the two arms at baseline visit and at final visit
Time frame: 4 weeks
Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit
Time frame: 4 weeks
Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms
Time frame: 4 weeks
Difference in the mean change in body weight between the 2 arms, from baseline to the final visit
Time frame: 4 weeks
Changes in waist and hip circumference
Time frame: 4 weeks
Changes in body fat content and fat free mass
Time frame: 4 weeks
Subjects global feeling of satiety
Time frame: 4 weeks
Food Craving Questionnaire
Time frame: 4 weeks
Global evaluation of efficacy by the subjects and investigators
Time frame: 4 weeks
Global evaluation of safety by the subjects and investigators
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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, MD principal investigator
Analyze & Realize
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 and Appetite Modulation (Focus of Study), 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 25 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit (time frame: 4 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 25 Mar 2015.