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).

Brief Summary

Detailed Description

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

Primary Outcomes

Secondary Outcomes

• Change in random blood sugar(From baseline (i.e. Day 1) to Day 21, Day 45)
• Change in HbA1C(From baseline (i.e. Day 1) to Day 45)
• Change in Hip, Waist, and Thigh Circumference(From baseline (i.e. Day 1) to Day 21, Day 45)
• Change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval)(From baseline (i.e. Day 1) to Day 45)
• Change in Lipoprotein lipids (HDL, LDL, Triglyceride, and Cholesterol)(From baseline (i.e. Day 1) to Day 45)
• Change in Serum Amylase(From baseline (i.e. Day 1) to Day 45)
• Change in AST and ALT levels(From baseline (i.e. Day 1) to Day 45)
• Improvement in Maximum Oxygen Consumption (VO2)(From baseline (i.e. Day 1) to Day 45)
• Percentage of subjects loosing weight(From baseline (i.e. Day 1) to Day 21, Day 45)
• Change in total Body fat(From baseline (i.e. Day 1) to Day 21, Day 45)
• Change in Serum Creatinine(From baseline (i.e. Day 1) to Day 45)
• Change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin(From baseline (i.e. Day 1) to Day 45)
• Change in BMI(From baseline (i.e. Day 1) to Day 21, Day 45)
• Test treatment perception and consumer feedback on 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.(From baseline (i.e. Day 1) to Day 21, Day 45)
• Change in Heart rate(From baseline (i.e. Day 1) to Day 21, Day 45)
• Change in Blood Pressure (Both)(From baseline (i.e. Day 1) to Day 21, Day 45)