Clinical trial NCT02930668: Efficacy and Safety of Glucosanol™ in Body Weight Reduction
Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing weight in the overweight and obese. The present study aims at expanding the data concerning the weight management effect of Glucosanol™ in overweight and moderately obese population.


Eligibility criteria: Inclusion Criteria:

* BMI 25 kg/m2 - 34,9 kg/m2
* Generally in good health• Desire to lose weight
* 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)• Readiness to take IP as recommended
* Readiness to avoid the use of other weight loss and/or management products and/or programs during the study
* Readiness to adhere to diet recommendation during the study
* Readiness to keep the habitual level of physical activity as prior to the study during the study
* Readiness and ability to complete the subject diary and study questionnaires
* Negative pregnancy testing (beta HCG-test in urine) at V1 in women of childbearing potential
* Women of childbearing potential: commitment to use contraception methods

Exclusion Criteria:

* Known allergy or hypersensitivity to the components of the investigational products
* Known allergy or hypersensitivity to members of the Fabaceae family
* Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
* Significant disorders:

  * untreated or unstable thyroid gland disorder
  * untreated or unstable hypertension (\>140/90 mm Hg)
  * acute or chronic gastrointestinal (GI) disease or malabsorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
  * diabetes mellitus- coagulation disorder- any other serious organ or systemic diseases that could influence the conduct and/or out-come of the study and/or could affect the tolerability of the subject (in the opinion of the investigator)
* Significant surgery within the last 6 months prior to V1:

  * GI surgery
  * liposuction
* History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to V1
* Clinically relevant excursions of safety laboratoryparameters
* Any electronic medical implant
* Regular use of anticoagulants
* 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. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, anti-diarrheals etc.) as per investigator judgement
  * for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)
* Consumption of food supplements or natural health products for the duration of the study
* Diet to lose and/or manage weight (except ac-cording to the study protocol)
* Vegetarian, vegan or macrobiotic diet
* Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
* Pregnancy or nursing
* History of or current abuse of drugs, alcohol or medication
* Inability to comply with study requirements
* Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
* Participation in another clinical study in the 30 days prior to V1 and during the study

Primary outcomes:
measure: Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube
Study officials:
affiliation: analyze & realize GmbH
name: Ralf Uebelhack, MD
role: PRINCIPAL_INVESTIGATOR
References: