NCT07098624

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

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is randomized, double-blinded, single-centre placebo-controlled, two-arms, clinical safety and efficacy study on Overweight and Obese (Class-I) subjects to evaluate the degree of weight change by regular intake of ACV Moringa. A total of 66 participants (33 Subjects per Test Treatment), including males and non-pregnant, non-lactating females aged between 18 and 65 years, who are overweight/ obese class-I subjects will be enrolled in the study. Participants will be randomized in a 1:1 ratio to receive either Treatment A or Treatment B. The study aims to complete evaluation for 46 participants (23 Subjects per Test Treatment) for the study. The potential subjects will be screened on the basis of the inclusion and exclusion criteria only after obtaining the written informed consent from the subjects. Subjects will be pre-screened by the Screening Department at NovoBliss Research based on their Body Mass Index (BMI). Subjects will be called contacted telephonically by the recruiting department prior to the enrolment visit. The subject will be requested to bring any previous medications and relevant laboratory reports on the day of the study visit. The subject will be asked to bring the past medications or laboratory reports along with on the study visit day. The subjects will be instructed to visit the facility as per the below visits: * Pre-screening * Visit 01 (Within 30 Days from Day 01): Screening, ICD Obtained, Screening Lab * Visit 02 (Day 01): Enrolment, Baseline Evaluations, Randomization, Test Treatment phase * Visit 03 (Day 45 +2 Days): Evaluations, Test Treatment phase * Visit 04 (Day 90 +2 Days): Final Evaluations, End of Study * Telephonic Follow-up: A structured telephonic follow-up schedule as mentioned below will be implemented to ensure adherence to study instruction, including diet restrictions and exercise routines. Additionally, daily text messages reminders will be sent to all enrolled subjects. * Daily diet adherence reminders will be sent at 8:00 AM (± 2 hours). * Daily exercise adherence reminders will also be sent at 8:00 AM (± 2 hours). * Weekly digital check-ins will be conducted via the mobile app every Friday. Assessments of efficacy parameters before the administration of the Test Treatments will be done one Day 01 and after the Test Treatment administration will be done on Day 45 (+2 Days) and 90 (+ 2 Days). Parameters include Anthropometric Parameters, Body composition, Athletic Endurance, Glycemic Parameters, Lipid Metabolism, Metabolic Markers, Inflammatory Biomarkers, Craving Control Biomarkers, Subjective Evaluation, Hematological Profile, Serum Biochemistry

Conditions

• Obese or Overweight Healthy Volunteers

Interventions

Type	Name	Description
OTHER	ACV Moringa Effervescent Tablets 4.3 g	Mode 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
OTHER	Placebo Effervescent Tablets 4.3 g	Mode 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

Timeline

• Start date: 2025-07-24
• Primary completion: 2025-10-24
• Completion: 2025-11-04
• First posted: 2025-08-01
• Last updated: 2025-08-01