A 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)
Condition: Body Weight in the Overweight and Obese Class - I Population
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      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.
    

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
    

Intervention name(s): Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules; Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules; Placebo (Resistant Dextrin) Capsules
Intervention type(s): Other; Other; Other
Intervention description(s): Mode of Usage: 2 capsules each time before 3 daily meals for consecutive 45 days.
Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.; Mode of Usage: 2 capsules each time before 3 daily meals for consecutive 45 days.
Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Three-arm, Comparative, Double-blinded, Placebo-controlled, Single-center, Dose-response, Safety and Efficacy
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care