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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
Full 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.
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Inclusion criteria
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:
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:
Women of childbearing potential:
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 criteria
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.:
Significant surgery within the last 6 months prior to V1 or planned within the study period:
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:
Any electronic medical implant
Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:
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
Primary purpose
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Interventional model
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178 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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