Body Weight in the Overweight and Obese Class - I PopulationNCT05711784
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)
A study testing Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules and Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules in people with Body Weight in the Overweight and Obese Class - I Population, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Body Weight in the Overweight and Obese Class - I Population
- What is being tested?
- Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules and Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteIndia
- Study dates
- 22 Feb 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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
- Being tested
- Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules, Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules, Placebo (Resistant Dextrin) Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phaseolean (White Kidney Bean Standardized Extract) 1500 mg CapsulesOther
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.
Phaseolean (White Kidney Bean Standardized Extract)3000 mg CapsulesOther
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.
Placebo (Resistant Dextrin) CapsulesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules | Experimental | 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. Receives: Other: Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules |
| Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules | Experimental | 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. Receives: Other: Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules |
| Placebo (Resistant Dextrin) Capsules | Placebo comparator | 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 Receives: Other: Placebo (Resistant Dextrin) Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 (inclusion) to 45 Days
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
Measured: Day 1 (inclusion) to 45 Days
Secondary outcomes (16)
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
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
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
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
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
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
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
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
Change in HbA1C
To evaluate the effectiveness of the test treatment for change in HbA1C between the treatment and placebo group
Measured: From baseline (i.e. Day 1) to Day 45
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
Measured: From baseline (i.e. Day 1) to Day 45
Change in Serum Creatinine
To evaluate the effectiveness of the test treatment for change in Serum Creatinine between the treatment and placebo group
Measured: From baseline (i.e. Day 1) to Day 45
Change in Serum Amylase
To evaluate the effectiveness of the test treatment for change in Serum Amylase between the treatment and placebo group
Measured: From baseline (i.e. Day 1) to Day 45
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
Measured: 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
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
Measured: From baseline (i.e. Day 1) to Day 45
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
Measured: From baseline (i.e. Day 1) to Day 45
Change in BMI
To evaluate the effectiveness of the test treatment for change in BMI between the treatment and placebo group
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Heart rate
To evaluate the effectiveness of the test treatment for change in Heart rate between the treatment and placebo group
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
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
Measured: From baseline (i.e. Day 1) to Day 45
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
Measured: 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.
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
Measured: From baseline (i.e. Day 1) to Day 21, Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start22 Feb 2023
- Primary completion25 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight in the Overweight and Obese Class - I PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Three-arm, Comparative, Double-blinded, Placebo-controlled, Single-center, Dose-response, Safety and Efficacy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711784
- Sponsor's protocol ID
- NB220038-AG
- Status last verified
- Jul 2024
- First submitted
- 13 Jan 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05711784
- Acronym / sponsor ID
- NB220038-AG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Three-arm, Comparative, Double-blinded, Placebo-controlled, Single-center, Dose-response, Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules | Experimental | Other: Phaseolean (White Kidney Bean Standardized Extract) 1500 mg CapsulesPhaseolus 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. |
| Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules | Experimental | Other: Phaseolean (White Kidney Bean Standardized Extract)3000 mg CapsulesPhaseolus 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. |
| Placebo (Resistant Dextrin) Capsules | Placebo comparator | Other: Placebo (Resistant Dextrin) CapsulesResistant 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phaseolean (White Kidney Bean Standardized Extract) 1500 mg CapsulesMode 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. | Other | Phaseolean (White Kidney Bean Standardized Extract)1500 mg Capsules |
| Phaseolean (White Kidney Bean Standardized Extract)3000 mg CapsulesMode 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. | Other | Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules |
| Placebo (Resistant Dextrin) CapsulesResistant 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 |
Primary outcome
Change in Weight (Unit: Kg)
Time frame: Day 1 (inclusion) to 45 Days
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)
Time frame: Day 1 (inclusion) to 45 Days
Mean percentage change in BMI in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
16 secondary outcomes
Percentage of subjects loosing weight
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Hip, Waist, and Thigh Circumference
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in total Body fat
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in random blood sugar
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in HbA1C
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Lipoprotein lipids (HDL, LDL, Triglyceride, and Cholesterol)
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Serum Creatinine
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Serum Amylase
Time frame: From baseline (i.e. Day 1) to Day 45
Change in AST and ALT levels
Time frame: 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
Time frame: From baseline (i.e. Day 1) to Day 45
Improvement in Maximum Oxygen Consumption (VO2)
Time frame: From baseline (i.e. Day 1) to Day 45
Change in BMI
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Heart rate
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval)
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Blood Pressure (Both)
Time frame: 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.
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Nayan K Patel, MBBS principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules and Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules in people with Body Weight in the Overweight and Obese Class - I Population, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (Unit: Kg) (time frame: Day 1 (inclusion) to 45 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.