AzTrials
AzTrials

OverweightNCT04086797

DBRPC Study to Evaluate the Efficacy and Safety of IQP-AE-103 in Overweight and Moderately Obese Subjects

A study testing IQP-AE-103 in people with Overweight and Obesity, run by Perrigo CSCI at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main study objective is to evaluate the efficacy of IQP-AE-103 in reducing body weight in overweight and moderately obese subjects, in the context of an energy restricted diet. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
IQP-AE-103
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
178 participants
Where
1 siteGermany
Study dates
11 Sep 2019to 8 Apr 2021
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women from 18 to 70 years old
  • Body mass index (BMI) 25 kg/m2 - 34.9 kg/m2
  • Having at least one of the following traits:
  • waist circumference ≥ 94 cm in men and ≥ 80 cm in women
  • triglyceride levels ≥ 150 mg/dL (1.7 mmol/L)
  • high-density lipoprotein cholesterol (HDL-C) levels: ≤ 40 mg/dL (1.0 mmol/L) in men and ≤ 50 mg/dL (1.3 mmol/L) in women
Show all 22Show fewer
  • blood pressure (BP), average value of the last two values of the triplicate measurement: systolic BP ≥ 130 mmHg, diastolic BP ≥ 85 mmHg
  • fasting blood glucose ≥ 100 mg/dL
  • Desire to lose weight
  • Readiness and ability to complete the study, according to investigator's judgement following the screening interview
  • Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
  • Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)
  • Subject's agreement to comply with study procedures, in particular:
  • to adhere to diet recommendation during the study
  • to take IP as recommended
  • to avoid the use of other weight loss and/or management products and/or programs during the study
  • to keep the habitual level of physical activity
  • to complete the subject diary and study questionnaires
  • Women of childbearing potential:
  • commitment to use contraception methods
  • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
  • Readiness not to participate in another clinical study during this study Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Who cannot join

  • Known allergy or hypersensitivity to the components of the investigational product or source plants
  • Pathological electrocardiogram (ECG) at V1
  • History and/or presence of clinically significant condition/ disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
  • untreated or unstable thyroid gland disorder
  • hypertension (regular systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
  • acute or chronic gastrointestinal (GI) disease or digestion/ absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
Show all 26Show fewer
  • diabetes mellitus
  • any other relevant serious organ or systemic diseases
  • Significant surgery within the last 6 months prior to V1 or planned within the study period:
  • GI surgery
  • liposuction
  • History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1
  • Deviation of safety laboratory parameter(s) at V1 (excluding those stated in the inclusion criteria) that is:
  • clinically significant or
  • >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
  • Any electronic medical implant
  • Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:
  • that could influence body weight (e.g. systemic corticosteroids)
  • that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.) as per investigator judgement
  • for weight management (e.g. fat binder, carbohydrate/ starch blocker, fat burner, satiety products, acupuncture etc.)
  • that could influence lipid levels, blood pressure and/or glycemic control
  • Self-reported smoking cessation within 6 months prior to V1 and/or during the study (regular smoking during the study at the same level as prior to the study is allowed)
  • Women of child-bearing potential: pregnancy or nursing
  • History of or current abuse of drugs, alcohol or medication
  • Participation in another study during the last 30 days prior to V1
  • Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • analyze & realize GmbH

    Berlin, 13467

Other trials in Germany

About this study

Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of IQP-AE-103 in Overweight and Moderately Obese Subjects

The main study objective is to evaluate the efficacy of IQP-AE-103 in reducing body weight in overweight and moderately obese subjects, in the context of an energy restricted diet. Further objectives are to evaluate the beneficial potential of IQP-AE-103 on waist circumference, blood pressure and blood glucose and lipid levels, quality of life, as well as its safety and tolerability

Read the detailed description

Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health. Obesity is a substantial public health problem throughout the world, with the prevalence increasing rapidly in numerous developing and developed nations. In 2014, about 13% of the world's adult populations were obese and 39% were overweight. The worldwide prevalence of obesity has more than doubled in over 30 years (WHO, 2016). Obesity and overweight pose major risks for serious diseases, such as dyslipidemia, type 2 diabetes, hypertension, coronary heart disease and stroke (Haslam \& James 2005) and average life expectancy is reduced in obese people (Fontaine et al. 2003). Dietary fat plays a major role in the development of overeating and obesity (Bray et al. 2004); thus fat uptake should be a main target to reduce energy intake and achieve a loss of body weight (Svendsen \& Tonstad, 2011). It has been shown that nutrients such as protein and fibre reduce lipid absorption (e.g. Chong et al., 2014; Hosomi et al., 2010; Tsujita et al., 2007). The main components of the IQP-AE-103 are okra (Abelmoschus esculentus (L.) Moench) pod powder and inulin. Okra pod powder contains a combination of dietary fibre and protein, which may have an important role in fat binding (Kumar et al., 2013). Dehydrated powder derived from okra pod has further been shown to have substantial swelling capabilities when added to water (Bakre \& Jaiyeaob, 2009), which can potentially provide satiety effects. Inulin is a fermentable fructan, derived from plants such as asparagus, garlic, leak, onion etc.

and serves as an important source of soluble dietary fibre (Jaundzeikare and Beitane, 2014), to further enhance the effect of fat binding. The efficacy of IQP-AE-103 in body weight reduction during intake of 12 weeks has been shown recently in a clinical trial with 108 overweight and moderately obese subjects (Uebelhack et al., 2019). The present study aims at a broader evaluation of the beneficial effects of IQP-AE-103 for use in weight management, including its impact on waist circumference, blood pressure and blood glucose and lipid levels as well as quality of life, in overweight and moderately obese subjects.

Conditions
Overweight, Obesity
Being tested
IQP-AE-103, Placebo
Keywords
IQP-AE-103, overweight treatment, obesity treatment
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-103Dietary supplement

    1980 mg

  • PlaceboDietary supplement

    Placebo

Study groups in NCT04086797
Study groupRoleWhat they receive
IQP-AE-103Experimental2 capsules after 3 main meals per day (total 1980 mg)
Receives: Dietary Supplement: IQP-AE-103
PlaceboPlacebo comparator2 capsules after 3 main meals per day
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in body weight

    Difference in body weight (kg) change after 24 weeks of IP intake, in comparison to baseline

    Measured: 24 weeks

Secondary outcomes (1)

  1. Difference in BMI

    Difference in BMI change after 24 weeks of IP intake, in comparison to baseline

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start11 Sep 2019
  3. Primary completion8 Apr 2021
  4. Study completion8 Apr 2021

Resources

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
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04086797
Sponsor's protocol ID
PERI/020918
Status last verified
Nov 2023
First submitted
10 Sep 2019
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uebelhack 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

Questions about this trial

What is this clinical trial studying?

A study testing IQP-AE-103 in people with Overweight and Obesity, run by Perrigo CSCI 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 22 inclusion and 26 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 28 Nov 2023. 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?

Difference in body weight (time frame: 24 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 NCT04086797, which also lists 1 linked publication.

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 28 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in