Efficacy and Safety of Glucosanol™ in Body Weight Reduction

NCT02930668 | Completed

• 1 other identifier: INQ/024115
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Low dose (Glucosanol 350mg)

EXPERIMENTAL

Each capsule contains Glucosanol / Phaselite 350mg Subjects will take 2 capsules three times a day, 30 mins before meals.

Dietary Supplement: Glucosanol 350mg

High dose (Glucosanol 500mg)

EXPERIMENTAL

Each capsule contains Glucosanol / Phaselite 500mg Subjects will take 2 capsules three times a day, 30 mins before meals.

Dietary Supplement: Glucosanol 500mg

Interventions

Glucosanol 350mg DIETARY_SUPPLEMENT

Low dose (Glucosanol 350mg)

Glucosanol 500mg DIETARY_SUPPLEMENT

High dose (Glucosanol 500mg)

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Barbara Grube

Berlin, 10709, Germany

Location

Related Publications (1)

• 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.

  PMID: 38830962 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ralf Uebelhack, MD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)