Status:
COMPLETED
DBRPC Study to Evaluate the Efficacy and Safety of IQP-AE-103 in Overweight and Moderately Obese Subjects
Lead Sponsor:
Perrigo CSCI
Collaborating Sponsors:
Analyze & Realize
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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. Further objectives ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.)
- 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
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04086797
Start Date
September 11 2019
End Date
April 8 2021
Last Update
November 28 2023
Active Locations (1)
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1
analyze & realize GmbH
Berlin, Germany, 13467