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)

NCT05711784 | Completed

• 1 other identifier: NB220038-AG
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight in the Overweight and Obese Class - I Population

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 1 (inclusion) to 45 Days

Secondary Outcomes (16)

• Percentage of subjects loosing weight

  From baseline (i.e. Day 1) to Day 21, Day 45

• Change in Hip, Waist, and Thigh Circumference

  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 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

Study Arms (3)

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.

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.

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

Other: Placebo (Resistant Dextrin) Capsules

Interventions

Phaseolean (White Kidney Bean Standardized Extract) 1500 mg Capsules OTHER

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)1500 mg Capsules

Phaseolean (White Kidney Bean Standardized Extract)3000 mg Capsules OTHER

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 Capsules

Placebo (Resistant Dextrin) Capsules OTHER

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

Placebo (Resistant Dextrin) Capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Ambe Phytoextracts Pvt. Ltd: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, India

Location

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dr Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Medical Director

Model Details: Randomized, Three-arm, Comparative, Double-blinded, Placebo-controlled, Single-center, Dose-response, Safety and Efficacy

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 3, 2023
• Study Start: February 22, 2023
• Primary Completion: April 25, 2023
• Study Completion: May 30, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)