Clinical Study to Assess the Safety and Efficacy of ACV Moringa Tablet Intake on Weight Management in Overweight and Mildly Obese Study Participants
Scientific Title of Study
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
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NB250004-ZV, Protocol Ver 1.0, 03Jul25
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nayan Patel MBBS
Designation
Principal Investigator
Affiliation
NovoBliss Research Pvt. Ltd.
Address
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmadabad GUJARAT 382481 India
Phone
07948983895
Fax
Email
dr.nayan@novobliss.in
Details of Contact Person Scientific Query
Name
Dr Nayan Patel MBBS
Designation
Principal Investigator
Affiliation
NovoBliss Research Pvt. Ltd.
Address
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmadabad GUJARAT 382481 India
Phone
07948983895
Fax
Email
dr.nayan@novobliss.in
Details of Contact Person Public Query
Name
Maheshvari Patel
Designation
Director Operations and Strategic Management
Affiliation
NovoBliss Research Pvt. Ltd.
Address
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmadabad GUJARAT 382481 India
Phone
07948983895
Fax
Email
maheshvari@novobliss.in
Source of Monetary or Material Support
Zywie Ventures Private Ltd
Plot No. 53, Near Metal Power Analytical,
Marol, Andheri East-Mumbai – 400059,
Maharashtra, India
Primary Sponsor
Name
Zywie Ventures Private Ltd
Address
Plot No. 53, Near Metal Power Analytical,
Marol, Andheri East-Mumbai – 400059,
Maharashtra, India
Mode of Administration: 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
Route of Administration: Oral
Comparator Agent
NIL
NA
Intervention
Placebo Effervescent Tablet 4.3 g
Mode of Administration: Dissolve one effervescent tablet in a full glass of water (approximately 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
Route of Administration: Oral
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Age: 18- 65 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Females of childbearing potential must have a self-reported negative urine pregnancy.
4) Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study
5) Subject is in good general health as determined by the Investigator on the basis of medical history.
6) 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).
7) Subjects with a total body fat percentage exceeding 25% for men and 30% for women using Bioimpedance test.
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 who agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate).
13) Subjects willing to follow the given diet and maintain their physical activity by a Diet and physical activity diary.
14) Subjects must possess an Android smartphone to facilitate daily app login and study-related activities.
15) Subjects are willing to give written informed consent and are willing to follow the study procedure.
16) Subjects who commit not to use any other medication for weight management other than the test treatment for the entire duration of the study.
17) Willing to use test treatment throughout the study period.
18) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
ExclusionCriteria
Details
1) Subjects BMI is between less than 25 and greater than 35 kg/m2.
2) 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.
3) Subjects with a history of gastrointestinal disorders, including chronic gastritis, gastric discomfort, or any diagnosed gastrointestinal conditions.
4) Subjects having drug and alcohol abuse.
5) Smokers and tobacco users.
6) Subjects having more than 5 kg variation in body weight within 3 months before study entry.
7) Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss.
8) Undergone surgery before 30 days of screening or planning to undergo surgery within the study period.
9) Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection.
10) 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.
11) Any other diseases/co-morbidity that is considered by the Investigator as an exclusion.
12) With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit.
13) Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
14) Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression.
15) Non-stable weight during the last 6 months (more than 5% change in total weight)
16) 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
17) Following or having followed a hypocaloric diet (energy intake less than 1,500 kCal/day) in the month preceding inclusion and/or likely to undertake this diet during the test.
18) Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
19) Using topical anti-cellulite treatments.
20) Pregnant or breastfeeding or planning to become pregnant during the study period.
21) Subject has a history of chronic illness which may influence the cutaneous state.
22) Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.
23) Any other condition which could warrant exclusion from the study, as per the Investigator’s discretion.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1.To assess the efficacy of test treatment by evaluating change in Body Weight using calibrated weighing machine at three predefined time points- Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days), assessed within each treatment group and across treatment groups.
Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Secondary Outcome
Outcome
TimePoints
1.To assess the efficacy of test treatment by evaluating change in Anthropometric Parameters using calibrated measuring tape assessed within each treatment group and across treatment groups
Day 01 , Day 45 , and Day 90
2.To assess the efficacy of test treatment by evaluating change in Total Fat Percentage using Bioimpedance Test assessed within each treatment group and across treatment groups.
Day 01 , Day 45 , and Day 90
3. To assess the efficacy of test treatment by evaluating change in VO2 Max using Treadmill Walking Test assessed within each treatment group and across treatment groups
Day 01 , Day 45 , and Day 90
4. To assess the efficacy of test treatment by evaluating change in Apolipoprotein- ApoA, ApoB, assessed within each treatment group and across treatment groups.
Day 01 , Day 45 , and Day 90
5.To assess the efficacy of test treatment by evaluating change in carbohydrate metabolism through Serum Blood Glucose and PPBG assessed within each treatment group and across treatment groups.
Day 01 , Day 45 and Day 90
6. To assess the efficacy of test treatment by evaluating change in Lipid metabolism through Total Cholesterol, HDL, LDL, Triglycerides assessed within each treatment group and across treatment groups.
30 Days from Day 01, Day 01 , Day 45 , and Day 90
7. To assess the efficacy of test treatment by evaluating change in Fatty Acid Oxidation Rate through Beta-hydroxybutyrate, assessed within each treatment group and across treatment groups
Day 01 , Day 45 , and Day 90
8. To assess the efficacy of test treatment by evaluating change in Metabolic Biomarkers through HOMA-IR , assessed within each treatment group and across treatment groups
Day 01 and Day 90
9. To assess the efficacy of test treatment by evaluating change in Inflammatory Biomarkers through IL-6, CRP, assessed within each treatment group and across treatment groups
Day 01 , Day 45 , and Day 90
Target Sample Size
Total Sample Size="66" Sample Size from India="66" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
09/07/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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 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 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 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 Treatment(s) will be done one Day 01 and after
the Test Treatment administration will be done on Day 45 (+ 2 Days) and 90 (+ 2
Days). Assessments include Anthropometric Parameters, Body composition, Athletic
Endurance, Glycemic Parameters , Lipid Metabolism, Metabolic Markers, Inflammatory
Biomarkers, Craving Control Biomarkers, Subjective Evaluation, Hematological
Profile, and Serum Biochemistry