NCT04086797

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Perrigo CSCI · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	IQP-AE-103	1980 mg
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2019-09-11
• Primary completion: 2021-04-08
• Completion: 2021-04-08
• First posted: 2019-09-12
• Last updated: 2023-11-28

Locations

1 site across 1 country: Germany