DBRPC Study to Evaluate the Efficacy and Safety of IQP-AE-103 in Overweight and Moderately Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

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 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
    

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.
    

Intervention name(s): IQP-AE-103; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1980 mg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IQP-AE-103; overweight treatment; obesity treatment