Efficacy and Safety of Glucosanol™ in Body Weight Reduction

NCT ID: NCT02930668

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Low dose (Glucosanol 350mg)

Each capsule contains Glucosanol / Phaselite 350mg

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

Group Type: EXPERIMENTAL

Glucosanol 350mg

Intervention Type: DIETARY_SUPPLEMENT

High dose (Glucosanol 500mg)

Each capsule contains Glucosanol / Phaselite 500mg

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

Group Type: EXPERIMENTAL

Glucosanol 500mg

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Glucosanol 350mg

Intervention Type: DIETARY_SUPPLEMENT

Glucosanol 500mg

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Uebelhack, MD

Role: PRINCIPAL_INVESTIGATOR

analyze & realize GmbH

Locations

Barbara Grube

Berlin, , Germany

Countries

Germany

References

Jager R, Abou Sawan S, Purpura M, Grube B, Roske Y, De Costa P, Chong PW. Proprietary alpha-amylase inhibitor formulation from white kidney bean (Phaseolus vulgaris L.) promotes weight and fat loss: a 12-week, double-blind, placebo-controlled, randomized trial. Sci Rep. 2024 Jun 3;14(1):12685. doi: 10.1038/s41598-024-63443-8.

Reference Type: DERIVED

PMID: 38830962 (View on PubMed)

Other Identifiers

INQ/024115

Identifier Type: -

Identifier Source: org_study_id