Health Condition 1: E66- Overweight and obesity
Conditions
Interventions
Intervention1: Treatment A: Phaseolean (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 Administrat
Sponsors
Ambe Phytoextracts Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age: 18 to 50 years (both inclusive) at the time of consent. 2)Sex: Healthy non-pregnant/non-lactating females and Males. 3)Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study. 4)Subject is generally in good health and willing to reduce weight. 5)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. 6)Willing to observe dietetic plan in accordance with dietitian evaluation, 7)Able and willing to participate in the study by complying with the protocol procedures. 8)Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study. 9)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. 10)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. 11)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. 12)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. 13)Subject is willing to come in fasting state for every study visit. 14)Subject is agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate). 15)Subject is willing to give written informed consent and are willing to follow the study procedure.
Exclusion criteria
Exclusion criteria: 1)Subject has a history of allergy or sensitivity to the test treatments ingredients. 2)Subject who has a history of allergy with products containing beans, white kidney beans. 3)Subjects BMI is between less than 25 and greater than 35 kg/m2. 4)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. 5)Subjects having drug and alcohol abuse. 6)Smokers and tobacco users. 7)Subjects having more than 5 kg variation in body weight within 3 months before study entry. 8)Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss. 9)Undergone surgery before 30 days of screening or planning to undergo surgery within the study period. 10)Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection. 11)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. 12)Any other diseases/co-morbidity that is considered by the Investigator as an exclusion. 13)With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit. 14)Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study, 15)Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression. 16)Non-stable weight during the last 6 months ( >5% change in total weight) 17)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 18)Following or having followed a hypocaloric diet (energy intake 19)Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting), 20)Using topical anti-cellulite treatments 21)Pregnant or breastfeeding or planning to become pregnant during the study period. 22)Subject has a history of chronic illness which may influence the cutaneous state. 23)Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks. 24)Any other condition which could warrant exclusion from the study, as per the Investigatorâ??s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in Body Weight in the overweight and Obese Class - I populationTimepoint: Frome baseline to day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of test treatment assessed in terms of change in Lipoprotein lipids (HDL, LDL, Triglycerides, and Cholesterol)Timepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of change in Random blood glucose (RBS)Timepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of difference in AST and ALT levelsTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of difference in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin)Timepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of difference in Blood PressureTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of difference in ECGTimepoint: From baseline (i.e. Day 1) to Day 45;Effect of test treatment assessed in terms of difference in Heart RateTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of difference in serum amylaseTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of difference in serum creatinineTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of improvement in Maximum Oxygen Consumption (VO2)Timepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of product perceptionTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of reduction in BMITimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of reduction in HbA1CTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms of reduction in Hip, Waist and thigh circumferenceTimepoint: From baseline (i.e. Day 1) to Day 21, Day 45;Effect of test treatment assessed in terms | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed