A Clinical Safety and Efficacy Study in Subjects With Overweight or Obese Class - I, to Evaluate … (NCT05711784) | Clinical Trial Compass
CompletedNot Applicable
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)
India66 participantsStarted 2023-02-22
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study.
Exclusion 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.