NovoBliss Research Pvt Ltd
Dr. Nayan Patel
A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract). This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg. 22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment.
Body Weight in the Overweight and Obese Class - I Population
Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules
Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules
Placebo (Resistant Dextrin) Capsules
Not Applicable
A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract). This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg. 22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits. Visit 01 (Within 30 Days): Screening, Baseline evaluations Visit 02 (Day 01): Enrolment & Treatment phase start Visit 03 (Day 21): Treatment Period, Evaluations Visit 04 (Day 45): Treatment Period, Evaluations & End of Study Visit Telephonic follow-up will be taken thrice a week (Monday, Wednesday and Friday) during an entire study to check compliance with the diet plan and study treatment. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to consume any weight-loss medications, or supplementation or topical anti-cellulite treatment during the study. Eligible subjects will be randomly assigned equally to one of three groups in a 1:1:1 ratio as follows: Arm A (Treatment A): Subjects will be given a test treatment of 1500 mg/day (2 capsules in the morning before breakfast, 2 capsules in the afternoon before lunch and 2 capsules at night before dinner; each capsule containing 250 mg Phaseolean (White Kidney Bean Standardized Extract) along with the diet regimen and exercise as advised by the clinical nutritionist /Dietician (Diet of 2000 kcal/day throughout the study and walking exercise for 45 mins daily for consecutive 45 Days). Arm B (Treatment B): Subjects will be given a test treatment of 3000 mg/day (2 capsules in the morning before breakfast, 2 capsules in the afternoon before lunch and 2 capsules at night before dinner; each capsule containing 500 mg Phaseolean (White Kidney Bean Standardized Extract) along with the diet regimen and exercise as advised by the clinical nutritionist /Dietician (Diet of 2000 kcal/day throughout the study and walking exercise for 45 mins daily for consecutive 45 Days). Arm C (Treatment C): Subjects will be given placebo capsules (2 capsules in the morning before breakfast, 2 capsules in the afternoon before lunch and 2 capsules at night before dinner; each capsule containing 250 mg Resistant Dextrin as Placebo along with the diet regimen and exercise as advised by the clinical nutritionist /Dietician (Diet of 2000 kcal/day throughout the study and walking exercise for 45 mins daily for consecutive 45 Days). Subjects will be followed up as per the schedule of assessments. Assessment of efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatments usage on Day 21 (+2 Days), & Day 45 (+2 Days) within treatments and between treatments as listed below. Anthropometry: Height, Weight, Body Mass Index (BMI), Hip and Waist Circumference Skinfold fat thickness Maximum Oxygen consumption (VO2) Vitals (Heart Rate, Blood Pressure) ECG and Chest X-Ray Blood Biochemical Parameters (Serum albumin, total protein, AST, ALT, glucose, BUN, uric acid, creatinine levels, Random Insulin) Biomarkers - Amylase, Lipid Profile, HbA1c Hedonic Questionnaires - about product perception and consumer feedback (Weight reduction, feeling of the light weight of the body, reduction of Hip and Waist circumference, reduction in skinfold fat thickness, hunger feeling, satiety level etc.) Digital Photographs: Body photographs with measurement of waist and hip circumference - before test treatment usage and after test treatment usage}}
Study Type : | Interventional |
Estimated Enrollment : | 66 participants |
Masking : | Double |
Masking Description : | Subjects will be randomly assigned in a 1:1:1 ratio to receive either treatment A or B or C. The randomization code will be generated by NovoBliss Research. The randomization schedule will be maintained under controlled access. Double Blind will be followed. The Investigator/Evaluator will be blinded to the randomization schedule. The sequence number as per the randomization schedule will be used as Randomization ID. Subjects will be randomly allocated to one of the three treatment groups, as per the randomization code. Neither the subject nor the Investigator/Evaluator shall be aware of the treatment allocation (Double Blind). To maintain blinding, the study staff who involves in treatment dispensing and distribution will not be involved in any other study-related activities. |
Primary Purpose : | Supportive Care |
Official Title : | A Randomized, Double-blinded, Placebo-controlled, Single-Centre, Comparative, Clinical Safety and Efficacy Study in Subjects With Overweight or Obese Class - I, to Evaluate the Degree of Significant Weight Loss by Regular Intake of Phaseolean (White Kidney Bean Standardized Extract). |
Actual Study Start Date : | February 22, 2023 |
Estimated Primary Completion Date : | April 25, 2023 |
Estimated Study Completion Date : | May 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules Phaseolus Vulgaris L. is rich in alpha-amylase and alpha-glucosidase inhibitor. It has been used for calories absorption through preventing or delaying the digestion of complex carbohydrate. |
Other: Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules |
Experimental: Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules Phaseolus Vulgaris L. is rich in alpha-amylase and alpha-glucosidase inhibitor. It has been used for calories absorption through preventing or delaying the digestion of complex carbohydrate. |
Other: Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules |
Placebo Comparator: Placebo (Resistant Dextrin) Capsules Resistant dextrin is a soluble fiber, derived from wheat or corn starch and is prepared by highly controlled partial hydrolysis and repolymerization of the dextrinization process |
Other: Placebo (Resistant Dextrin) Capsules |
Ages Eligible for Study: | 18 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India,