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

NCT07098624 | Not Yet Recruiting

• 1 other identifier: NB250004-ZV
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Obese or Overweight Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

Secondary Outcomes (9)

• Change in Anthropometric Parameters using calibrated measuring tape

  Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

• Change in total Fat percentage using Bioimpedance Test

  Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

• Change in VO2 Max using Treadmill Walking Test

  Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

• Change in Apolipoprotein - ApoA, ApoB

  Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

• Change in carbohydrate metabolism through Serum Blood Glucose and PPBG

  Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)

Study Arms (2)

ACV Moringa Effervescent Tablets 4.3 g

EXPERIMENTAL

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

Placebo Effervescent Tablets 4.3 g

PLACEBO COMPARATOR

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: ACV Moringa Effervescent Tablets 4.3 g

Interventions

ACV Moringa Effervescent Tablets 4.3 g OTHER

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

Placebo Effervescent Tablets 4.3 g

Placebo Effervescent Tablets 4.3 g OTHER

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

ACV Moringa Effervescent Tablets 4.3 g

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Undergone surgery before 30 days of screening or planning to undergo surgery within the study period.
• Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection.
• 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.
• With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit.
• Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
• 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)
• Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Zywie Ventures Pvt Ltd: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nayan Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 1, 2025
• Study Start: July 24, 2025
• Primary Completion: October 24, 2025
• Study Completion: November 4, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share