Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Meal replacement formula: Study 1A -
50 gm, one sachet daily for dinner, oral route of administration, consume with water as meal, consume for 90 days
Intervention2: SlimSEB: Study 1A -
Sponsors
Advanced Enzymes Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Study 1A 1. Self reported healthy adults between 18 to 65 years 2. Individuals with a BMI ranging from 35 to 45 kg/m2, inclusive 3. Weight stable 3 kg weight loss or gain in the past 2 months 4. Able to give free, informed and express consent to participate 5. Individuals seeking to consult a nutritionist for personalized weight-loss diet plan 6. Participants should be in overall good physical and mental health, not regularly using any medications or dietary supplements, and must be willing to discontinue probiotic supplements probiotic enriched products and fibre supplements if applicable for at least the last 2 months prior to enrolment. They should also commit to maintaining a consistent dietary pattern throughout the study period. 7. Individuals judged appropriate for the study by the attending physician. 8. Willingness to complete all study visits, assessment questionnaires, and diaries. Study 1B 1. Eligible individuals from study 1A who have lost greater than or equal to 5% of their body weight in last 3 months due to IP 2. Willing to sign ICF
Exclusion criteria
Exclusion criteria: Study 1A 1. Diagnosed with a general physical or mental health problem e.g. peptic ulcer, inflammatory bowel disease, depression, anxiety, insomnia, acute metabolic complications, endocrine diseases, hypoglycaemia, etc. or systemic disease that may pose a safety risk, interfere with the dietary intake of the investigational product, or impact the assessment of study outcomes. 2. Cardiovascular diseases or medical conditions unsuitable for exercise, hypertension, metabolic disorders or concurrent dietary supplement use. 3. Taking weight or appetite affecting medications or drugs like selective serotonin reuptake inhibitors SSRIs, GLP-1 receptor agonists and steroids and gastrointestinal motility-affecting medications. 4. Liver function damage, Urinary or reproductive system infection, renal dysfunction. 5. Chronic diseases like cancer, chronic obstructive pulmonary disease, asthma, chronic gut diseases, nephropathy, psychoses, dementia, hypothyroid 6. Individuals likely to develop an allergy to the test substance like milk products and lactose intolerant. 7. Participants must not be currently enrolled in another clinical trial or planning to enroll in one during the study period and must comply with the required exclusion period following participation in any prior study. 8. Diagnosed with an autoimmune disease or are immune compromised due to medical condition or medications intake e.g. acquired immunodeficiency HIV, organ transplant, lymphoma, chemotherapy, chronic corticosteroids intake, etc. 9. Chronic alcohol/drugs/tobacco dependency/addicted. 10. Pregnant women, women desiring to become pregnant, or lactating women. 11. History of any surgery in the past 3 months. 12. Individuals judged inappropriate for the study by the attending physician Study 1B 1. Participants with side effect to the IP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1A Anthropometric parameters 1. Evaluation of change in body weight 2. Evaluation of change in BMI 3. Evaluation of change in body measurements Study 1B Anthropometric parameters 1. Evaluation of change in body weight 2. Evaluation of change in BMI 3. Evaluation of change in body measurementsTimepoint: Study 1A Day 1, 2, 47, 92 Study 1B Day 92, 93, 138, 183 | — |
Secondary
| Measure | Time frame |
|---|---|
| Study 1A 1. Changes in glucose and insulin related parameters i. Fasting plasma glucose FPG mmol/L ii. Fasting insulin micro IU/mL iii. Hemoglobin A1c HbA1c % iv. Homeostatic Model Assessment for Insulin Resistance HOMAIR v. Homeostasis model assessment of beta-cell function HOMA beta vi. Disposition index DI vii. Quantitative insulin sensitivity checks index QUICKI 2. Change in lipid profile i. Total cholesterol mg/dL ii. LDL-C mg/dL iii. HDL-C mg/dL iv. VLDL-C mg/dL v. Triglycerides mg/dL 3. Change in vital physical indicators i. Body temperature ii. Systolic blood pressure iii. Diastolic blood pressure iv. Pulse rate v. Respiration rateTimepoint: Study 1A Day 1, 2, 47, 92;Study 1A 4. Change in hematological parameters i. Hematological-Complete and differential blood count, platelets. ii. Biochemical-Serum Glutamic-Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, serum creatinine, blood urea nitrogen, random blood sugar, total cholesterol, total albumin and globulin and C-Reactive Protein, Thyroid TSH, T3, T4 5. Body Mass Composition Assessment 6. Assessment of tolerability i. The investigator will evaluate tolerability by asking the subject for any side effects or discomfort. 7. Assessment of Quality of life i. The quality of life will be assessed during each visit. 8. Adverse events and serious adverse events: i. Any adverse or Serious adverse event occurred during the study will be recorded.Timepoint: Study 1A Day 1, 2, 47, 92;Study 1B 1. Changes in glucose and insulin related parameters i. Fasting plasma glucose FPG mmol/L ii. Fasting insulin micro IU/mL iii. Hemoglobin A1c HbA1c % iv. Homeostatic Model Assessment for Insulin Resistance HOMAIR v. Homeostasis model assessment of beta-cell function HOMA beta vi. Disposition index DI vii. Quantitative insulin sensitivity checks index QUICKI 2. Change in lipid profile i. Total cholesterol mg/dL ii. LDL-C mg/dL iii. HDL-C mg/dL iv. VLDL-C mg/dL v. Trigly | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Advanced Enzymes Technologies Ltd
Outcome results
None listed