CompletedNCT05711784Updated Aug 1, 2024

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)

An interventional study of Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules and Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules in Body Weight in the Overweight and Obese Class - I Population, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Read the detailed description

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

Conditions studied

Body Weight in the Overweight and Obese Class - I Population

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In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 66 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

NovoBliss Research Pvt Ltd is the lead sponsor of 45 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 66 participants (actual)

Study arms

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

Interventions

OtherPhaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules
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.
OtherPhaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules
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.
OtherPlacebo (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

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: Day 1 (inclusion) to 45 Days

Secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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.
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

Study locations

1 site

NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05711784
Lead sponsor: NovoBliss Research Pvt Ltd
Collaborators: Ambe Phytoextracts Pvt. Ltd
Responsible party: Dr Nayan Patel (Principal Investigator - Medical Director, NovoBliss Research Pvt Ltd) — Principal investigator
First posted: Feb 3, 2023
Start date: Feb 22, 2023
Primary completion: Apr 25, 2023
Completion: May 30, 2023
Last update: Aug 1, 2024

Study contacts

Dr Nayan K Patel, MBBS

principal investigator · Medical Director

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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