OverweightNCT03058367
Benefit and Tolerability of IQP-AE-103 in Weight Loss
A study testing IQP-AE-103 (330mg) and IQP-AE-103 (165mg) in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial summary
This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg daily) in reducing body weight in overweight and moderately obese subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- IQP-AE-103 (330mg) and IQP-AE-103 (165mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 28 Nov 2017
- Phase
- Interventional
- 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
- Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Commitment to take IP as recommended
- Commitment to adhere to diet recommendation during the study
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- Commitment to maintain habitual level of activity/exercise during the study
- Consistent and stable body weight for 3 months prior to V1
- Commitment to avoid the use of other weight management products or programs during study
- Commitment and ability to complete the subject diary and study questionnaires
- Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period
- Consents to participate, understands requirements of the study and is willing to comply
Who cannot join
- Known sensitivity to the ingredients of the investigational product or source of ingredients
- Pregnancy or nursing
- Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
- Current or history of abuse of drugs, alcohol or medication
- Clinically relevant excursions of safety laboratory parameter
- Diabetes mellitus type 1
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- Untreated or unstable diabetes mellitus type 2
- Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
- Stenosis in the gastrointestinal (GI) tract
- Bariatric surgery in subject´s medical history
- Abdominal surgery within the last 6 months prior to V1
- Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.)
- Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis)
- Digestion/absorption disorders in gastrointestinal (GI) tract
- History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1
- Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1
- Any electronic medical implant
- Use of any medication that could influence GI functions such as antibiotics within 4 weeks and any laxatives, opioids, glucocorticoids, anticholinergics within last 3 months prior to V1 and during the study, as per investigator judgement
- Any medication or use of products for the treatment of obesity (e.g. orlistat, other fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.) within last 3 months prior to V1 and during the study
- Participation in similar studies or weight loss programs within last 4 weeks prior to V1
- Participation in other studies during the last 4 weeks prior to V1
- Inability to comply
- Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomised, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects
This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg daily) in reducing body weight in overweight and moderately obese subjects
- Conditions
- Overweight, Obesity
- Being tested
- IQP-AE-103 (330mg), IQP-AE-103 (165mg), Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-AE-103 (330mg)Dietary supplement
High dose capsules
IQP-AE-103 (165mg)Dietary supplement
Low dose capsules
PlaceboDietary supplement
Placebo identical to verum capsules
| Study group | Role | What they receive |
|---|---|---|
| High dose IQP-AE-103 (1980mg) | Experimental | 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks Receives: Dietary Supplement: IQP-AE-103 (330mg) |
| Low dose IQP-AE-103 (990mg) | Experimental | 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks Receives: Dietary Supplement: IQP-AE-103 (165mg) |
| Placebo | Placebo comparator | 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks 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 (kg)
Difference in mean change of body weight (kg) between the higher dosed verum (1980 mg a day) and placebo group after 12 weeks of intervention in comparison to baseline.
Measured: 12 weeks
Secondary outcomes (5)
Mean change in body weight (kg)
Changes in body weight (kg) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group
Measured: 2, 4, 8, 12 weeks
Mean change in body weight (%)
Changes in body weight (%) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group
Measured: 2, 4, 8, 12 weeks
Proportion of subject weight loss
Proportion of subjects who lost at least 3% and 5% of baseline body weight after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Measured: 2, 4, 8, 12 weeks
Change in waist circumference (cm)
Changes in waist circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Measured: 2, 4, 8, 12 weeks
Change in hip circumference (cm)
Changes in hip circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline
Measured: 2, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 May 2017
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058367
- Sponsor's protocol ID
- INQ/023314
- Status last verified
- Jan 2018
- First submitted
- 15 Feb 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng LV, Cooper J, De Costa P, Chong PW. Microbiota Composition and Diversity in Weight Loss Population After the Intake of IQP-AE-103 in a Double-Blind, Randomized, Placebo-Controlled Study. Front Nutr. 2022 Apr 28;9:790045. doi: 10.3389/fnut.2022.790045. eCollection 2022.
PubMed 35571928Uebelhack R, Bongartz U, Seibt S, Bothe G, Chong PW, De Costa P, Wszelaki N. Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects. J Obes. 2019 Feb 3;2019:3412952. doi: 10.1155/2019/3412952. eCollection 2019.
PubMed 30863632
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects
- ClinicalTrials.gov ID
- NCT03058367
- Acronym / sponsor ID
- INQ/023314
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 20 Feb 2017 (actual)
- 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.
This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg daily) in reducing body weight in overweight and moderately obese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose IQP-AE-103 (1980mg) | Experimental | Dietary Supplement: IQP-AE-103 (330mg)2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks |
| Low dose IQP-AE-103 (990mg) | Experimental | Dietary Supplement: IQP-AE-103 (165mg)2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 65 years
- Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Commitment to take IP as recommended
Key exclusion criteria (23 listed)
- Known sensitivity to the ingredients of the investigational product or source of ingredients
- Pregnancy or nursing
- Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
- Current or history of abuse of drugs, alcohol or medication
- Clinically relevant excursions of safety laboratory parameter
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-AE-103 (330mg)High dose capsules | Dietary supplement | High dose IQP-AE-103 (1980mg) |
| IQP-AE-103 (165mg)Low dose capsules | Dietary supplement | Low dose IQP-AE-103 (990mg) |
| PlaceboPlacebo identical to verum capsules | Dietary supplement | Placebo |
Primary outcome
Mean change in body weight (kg)
Time frame: 12 weeks
Difference in mean change of body weight (kg) between the higher dosed verum (1980 mg a day) and placebo group after 12 weeks of intervention in comparison to baseline.
5 secondary outcomes
Mean change in body weight (kg)
Time frame: 2, 4, 8, 12 weeks
Mean change in body weight (%)
Time frame: 2, 4, 8, 12 weeks
Proportion of subject weight loss
Time frame: 2, 4, 8, 12 weeks
Change in waist circumference (cm)
Time frame: 2, 4, 8, 12 weeks
Change in hip circumference (cm)
Time frame: 2, 4, 8, 12 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 3 Jan 2018.
- Derived from this study: PubMed 35571928Peng LV, Cooper J, De Costa P, Chong PW. Microbiota Composition and Diversity in Weight Loss Population After the Intake of IQP-AE-103 in a Double-Blind, Randomized, Placebo-Controlled Study. Front Nutr. 2022 Apr 28;9:790045. doi: 10.3389/fnut.2022.790045. eCollection 2022.
- Derived from this study: PubMed 30863632Uebelhack R, Bongartz U, Seibt S, Bothe G, Chong PW, De Costa P, Wszelaki N. Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects. J Obes. 2019 Feb 3;2019:3412952. doi: 10.1155/2019/3412952. eCollection 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQP-AE-103 (330mg) and IQP-AE-103 (165mg) in people with Overweight and Obesity, 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 12 inclusion and 23 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 3 Jan 2018. 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.
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?
Mean change in body weight (kg) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058367, which also lists 2 linked publications.
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 3 Jan 2018.