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Efficacy and Safety of Glucosanol™ in Body Weight Reduction

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ClinicalTrials.gov Identifier: NCT02930668
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dietary Supplement: Glucosanol 350mg Dietary Supplement: Glucosanol 500mg Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects
Study Start Date : May 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Placebo Comparator: Placebo

The placebo is identical in shape, colour and size to the active comparator with the active ingredient replaced with microcrystalline cellulose.

Subjects will take 2 capsules three times a day, 30 mins before meals.

Dietary Supplement: Placebo
Experimental: Low dose (Glucosanol 350mg)

Each capsule contains Glucosanol / Phaselite 350mg

Subjects will take 2 capsules three times a day, 30 mins before meals.

Dietary Supplement: Glucosanol 350mg
Experimental: High dose (Glucosanol 500mg)

Each capsule contains Glucosanol / Phaselite 500mg

Subjects will take 2 capsules three times a day, 30 mins before meals.

Dietary Supplement: Glucosanol 500mg



Primary Outcome Measures :
  1. Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930668


Locations
Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Ralf Uebelhack, MD analyze & realize GmbH

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT02930668     History of Changes
Other Study ID Numbers: INQ/024115
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms