Clinical Study to Assess the Safety and Efficacy of ACV Moringa Effervescent Tablet Intake on Weight Management in Overweight and Class I Obese Study Participants

Korábbi kezelés

• Subjects having drug and alcohol abuse.
• 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.
• 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.
• Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,

Más betegség

• 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 with a history of gastrointestinal disorders, including chronic gastritis, gastric discomfort, or any diagnosed gastrointestinal conditions.
• Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection.
• Any other diseases/co-morbidity that is considered by the Investigator as an exclusion.
• Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
• Subject has a history of chronic illness which may influence the cutaneous state.
• Any other condition which could warrant exclusion from the study, as per the Investigator's discretion.

Laborértékek

• With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit.

Egyéb

• Subjects BMI is between less than 25 and greater than 35 kg/m2.
• Smokers and tobacco users.
• 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.
• Using topical anti-cellulite treatments.
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.

• Age: 18- 65 years (both inclusive) at the time of consent.
• Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
• Females of childbearing potential must have a self-reported negative urine pregnancy.
• Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study
• Subject is in good general health as determined by the Investigator on the basis of medical history.
• Subjects who are classified as overweight (BMI 25.0-29.9 kg/m²) or as having Class I obesity (BMI 30.0-34.9 kg/m²).
• Subjects with a total body fat percentage exceeding 25% for men and 30% for women using Bioimpedance test.
• 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 who agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate).
• Subjects willing to follow the given diet and maintain their physical activity by a Diet and physical activity diary.
• Subjects must possess an Android smartphone to facilitate daily app login and study-related activities.
• Subjects are willing to give written informed consent and are willing to follow the study procedure.
• Subjects who commit not to use any other medication for weight management other than the test treatment for the entire duration of the study.
• Willing to use test treatment throughout the study period.
• Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.