A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Centre, Clinical Study to Evaluate the Safety and Efficacy of Intake of ACV Moringa on the Degree of Weight Change in Overweight and Class I Obese Study Participants
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
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 with a history of gastrointestinal disorders, including chronic gastritis, gastric discomfort, or any diagnosed gastrointestinal conditions.
Subjects having drug and alcohol abuse.
Parallel
ACV Moringa Effervescent Tablets 4.3 g
Other interventionMode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Twice daily, once before lunch and once before dinner Storage condition: Room temperature (15°C to 30°C) Route of Administration: Oral
Placebo Effervescent Tablets 4.3 g
Other interventionMode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Twice daily, once before lunch and once before dinner Storage condition: Room temperature (15°C to 30°C) Route of Administration: Oral
Change in body weight using calibrated weighing machine
To assess the efficacy of test treatment by evaluating change in body weight in Kg assessed within each treatment group and across treatment groups
Change in Anthropometric Parameters using calibrated measuring tape
To assess the efficacy of test treatment by evaluating change in Anthropometric Parameters (Body weight in kg Waist circumference in cm Hip circumference in cm Height in meter and BMI) assessed within each treatment group and across treatment groups.
Change in total Fat percentage using Bioimpedance Test
To assess the efficacy of test treatment by evaluating change in total Fat percentage assessed within each treatment group and across treatment groups
Change in VO2 Max using Treadmill Walking Test
To assess the efficacy of test treatment by evaluating change in VO2 Max (mL/kg/min) assessed within each treatment group and across treatment groups.
Change in Apolipoprotein - ApoA, ApoB
To assess the efficacy of test treatment by evaluating change in Apolipoprotein (mg/dL) - ApoA, ApoB assessed within each treatment group and across treatment groups.
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NovoBliss Research Pvt Ltd
Lead sponsor
Zywie Ventures Pvt Ltd
Collaborator
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