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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)

Primary Purpose

Body Weight in the Overweight and Obese Class - I Population

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules
Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules
Placebo (Resistant Dextrin) Capsules
Sponsored by
NovoBliss Research Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Body Weight in the Overweight and Obese Class - I Population

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified. Age: 18 to 50 years (both inclusive) at the time of consent. Sex: Healthy non-pregnant/non-lactating females and Males. Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study. Subject is generally in good health and willing to reduce weight. Overweight to Obese Class - I, BMI between or equal to 25 to 35 kg/m2, or total fat percentage reaching: men > 25% and women > 30% using Karada Scan. Willing to observe dietetic plan in accordance with dietitian evaluation, Able and willing to participate in the study by complying with the protocol procedures. Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study. Subject is willing to participate in exercise program (Daily, 45 mins brisk walking for consecutive 45 Days of treatment period) and recording to subject diary card. Subject is willing to come in fasting state for every study visit. Subject is agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate). Subject is willing to give written informed consent and are willing to follow the study procedure Exclusion Criteria: Subjects must not be enrolled in the study if they meet any one of the following criteria: Subject has a history of allergy or sensitivity to the test treatments ingredients. Subject who has a history of allergy with products containing beans, white kidney beans. Subjects BMI is between less than 25 and greater than 35 kg/m2. Subjects having past or present history or clinically significant findings indicating cardiovascular disease, type 2 diabetes mellitus, hypertension, endocrine, pulmonary, neurological or psychological disorders, hypo or hyperthyroidism and renal disorders. Subjects having drug and alcohol abuse. Smokers and tobacco users. Subjects having more than 5 kg variation in body weight within 3 months before study entry. Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss. Undergone surgery before 30 days of screening or planning to undergo surgery within the study period. Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection. Participation in other drugs, investigational medicinal product, any herbal products and/or cosmetics intended to weight loss clinical trials within 3 months before enrolment in this trial. Any other diseases/co-morbidity that is considered by the Investigator as an exclusion. With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit. Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study, Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression. Non-stable weight during the last 6 months (>5% change in total weight) Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and/or likely to take during the test Following or having followed a hypocaloric diet (energy intake <1,500 kCal/day) in the month preceding inclusion and/or likely to undertake this diet during the test. Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting), Using topical anti-cellulite treatments Pregnant or breastfeeding or planning to become pregnant during the study period. Subject has a history of chronic illness which may influence the cutaneous state. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks. Any other condition which could warrant exclusion from the study, as per the Investigator's discretion

Sites / Locations

  • NovoBliss Research Pvt LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules

Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules

Placebo (Resistant Dextrin) Capsules

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change in Weight (Unit: Kg)
Mean percentage change in Body Weight in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Change in BMI (Unit: Kg/m2)
Mean percentage change in BMI in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group

Secondary Outcome Measures

Percentage of subjects loosing weight
To evaluate the effectiveness of the test treatment in terms of percentage of subjects loosing weight between the treatment and placebo group
Change in Hip, Waist, and Thigh Circumference
To evaluate the effectiveness of the test treatment for change in Hip, waist, and thigh circumference between the treatment and placebo group
Change in total Body fat
To evaluate the effectiveness of the test treatment for change in total body fat by measuring skinfold fat thickness between the treatment and placebo group
Change in random blood sugar
To evaluate the effectiveness of the test treatment for change in random blood sugar between the treatment and placebo group
Change in HbA1C
To evaluate the effectiveness of the test treatment for change in HbA1C between the treatment and placebo group
Change in Lipoprotein lipids (HDL, LDL, Triglyceride, and Cholesterol)
To evaluate the effectiveness of the test treatment for change in Lipoprotein Lipids (HDL, LDL, Triglyceride, and Cholesterol) between the treatment and placebo group
Change in Serum Creatinine
To evaluate the effectiveness of the test treatment for change in Serum Creatinine between the treatment and placebo group
Change in Serum Amylase
To evaluate the effectiveness of the test treatment for change in Serum Amylase between the treatment and placebo group
Change in AST and ALT levels
To evaluate the effectiveness of the test treatment for change in AST and ALT levels between the treatment and placebo group
Change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin
To evaluate the effectiveness of the test treatment for change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin between the treatment and placebo group
Improvement in Maximum Oxygen Consumption (VO2)
To evaluate the effectiveness of the test treatment for improvement in Maximum Oxygen Consumption between the treatment and placebo group
Change in BMI
To evaluate the effectiveness of the test treatment for change in BMI between the treatment and placebo group
Change in Heart rate
To evaluate the effectiveness of the test treatment for change in Heart rate between the treatment and placebo group
Change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval)
To evaluate the effectiveness of the test treatment for change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval) between the treatment and placebo group
Change in Blood Pressure (Both)
To evaluate the effectiveness of the test treatment for change in Blood Pressure (Both) between the treatment and placebo group
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.
To evaluate the Effect of test treatment in terms of 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 - using hedonic questionnaires

Full Information

First Posted
January 13, 2023
Last Updated
February 28, 2023
Sponsor
NovoBliss Research Pvt Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05711784
Brief Title
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)
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).
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
April 11, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NovoBliss Research Pvt Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight in the Overweight and Obese Class - I Population

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Three-arm, Comparative, Double-blinded, Placebo-controlled, Single-center, Dose-response, Safety and Efficacy
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules
Arm Type
Experimental
Arm Description
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.
Arm Title
Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Resistant Dextrin) Capsules
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo (Resistant Dextrin) Capsules
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Weight (Unit: Kg)
Description
Mean percentage change in Body Weight in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Time Frame
Day 1 (inclusion) to 45 Days
Title
Change in BMI (Unit: Kg/m2)
Description
Mean percentage change in BMI in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Time Frame
Day 1 (inclusion) to 45 Days
Secondary Outcome Measure Information:
Title
Percentage of subjects loosing weight
Description
To evaluate the effectiveness of the test treatment in terms of percentage of subjects loosing weight between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
Change in Hip, Waist, and Thigh Circumference
Description
To evaluate the effectiveness of the test treatment for change in Hip, waist, and thigh circumference between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
Change in total Body fat
Description
To evaluate the effectiveness of the test treatment for change in total body fat by measuring skinfold fat thickness between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
Change in random blood sugar
Description
To evaluate the effectiveness of the test treatment for change in random blood sugar between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
Change in HbA1C
Description
To evaluate the effectiveness of the test treatment for change in HbA1C between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in Lipoprotein lipids (HDL, LDL, Triglyceride, and Cholesterol)
Description
To evaluate the effectiveness of the test treatment for change in Lipoprotein Lipids (HDL, LDL, Triglyceride, and Cholesterol) between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in Serum Creatinine
Description
To evaluate the effectiveness of the test treatment for change in Serum Creatinine between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in Serum Amylase
Description
To evaluate the effectiveness of the test treatment for change in Serum Amylase between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in AST and ALT levels
Description
To evaluate the effectiveness of the test treatment for change in AST and ALT levels between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin
Description
To evaluate the effectiveness of the test treatment for change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Improvement in Maximum Oxygen Consumption (VO2)
Description
To evaluate the effectiveness of the test treatment for improvement in Maximum Oxygen Consumption between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in BMI
Description
To evaluate the effectiveness of the test treatment for change in BMI between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
Change in Heart rate
Description
To evaluate the effectiveness of the test treatment for change in Heart rate between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
Change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval)
Description
To evaluate the effectiveness of the test treatment for change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval) between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 45
Title
Change in Blood Pressure (Both)
Description
To evaluate the effectiveness of the test treatment for change in Blood Pressure (Both) between the treatment and placebo group
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45
Title
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.
Description
To evaluate the Effect of test treatment in terms of 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 - using hedonic questionnaires
Time Frame
From baseline (i.e. Day 1) to Day 21, Day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified. Age: 18 to 50 years (both inclusive) at the time of consent. Sex: Healthy non-pregnant/non-lactating females and Males. Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study. Subject is generally in good health and willing to reduce weight. Overweight to Obese Class - I, BMI between or equal to 25 to 35 kg/m2, or total fat percentage reaching: men > 25% and women > 30% using Karada Scan. Willing to observe dietetic plan in accordance with dietitian evaluation, Able and willing to participate in the study by complying with the protocol procedures. Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study. Subject is willing to participate in exercise program (Daily, 45 mins brisk walking for consecutive 45 Days of treatment period) and recording to subject diary card. Subject is willing to come in fasting state for every study visit. Subject is agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate). Subject is willing to give written informed consent and are willing to follow the study procedure Exclusion Criteria: Subjects must not be enrolled in the study if they meet any one of the following criteria: Subject has a history of allergy or sensitivity to the test treatments ingredients. Subject who has a history of allergy with products containing beans, white kidney beans. Subjects BMI is between less than 25 and greater than 35 kg/m2. Subjects having past or present history or clinically significant findings indicating cardiovascular disease, type 2 diabetes mellitus, hypertension, endocrine, pulmonary, neurological or psychological disorders, hypo or hyperthyroidism and renal disorders. Subjects having drug and alcohol abuse. Smokers and tobacco users. Subjects having more than 5 kg variation in body weight within 3 months before study entry. Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss. Undergone surgery before 30 days of screening or planning to undergo surgery within the study period. Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection. Participation in other drugs, investigational medicinal product, any herbal products and/or cosmetics intended to weight loss clinical trials within 3 months before enrolment in this trial. Any other diseases/co-morbidity that is considered by the Investigator as an exclusion. With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit. Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study, Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression. Non-stable weight during the last 6 months (>5% change in total weight) Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and/or likely to take during the test Following or having followed a hypocaloric diet (energy intake <1,500 kCal/day) in the month preceding inclusion and/or likely to undertake this diet during the test. Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting), Using topical anti-cellulite treatments Pregnant or breastfeeding or planning to become pregnant during the study period. Subject has a history of chronic illness which may influence the cutaneous state. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks. Any other condition which could warrant exclusion from the study, as per the Investigator's discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maheshvari N Patel, M.Pharma
Phone
91-9909013236
Email
maheshvari@novobliss.in
First Name & Middle Initial & Last Name or Official Title & Degree
Sheetal J Khandwala, B.Com
Email
bd@novobliss.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Nayan K Patel, MBBS
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
NovoBliss Research Pvt Ltd
City
Ahmedabad
State/Province
Gujarat
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maheshvari N Patel, MPharm

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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