Health Condition 1: E668- Other obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 21–65 years (men or women) 2.BMI 25–35 kg/m² 3.Newly initiated on Fast&Up Lean Body 4.Willing to follow physician-recommended lifestyle/diet/exercise advice 5.Willing to comply with product intake and follow-up visits 6.Willing to provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women 2.Known hypersensitivity to L-Carnitine Tartrate or excipients 3.Severe hepatic dysfunction, severe renal impairment, or hypertension 4.Obesity due to hormonal conditions (e.g., hypothyroidism, PCOS, T2DM) 5.Use of weight-reducing supplements/medications, hormonal therapy, pre/pro/synbiotics, multivitamins, antacids, antibiotics, steroids, laxatives within last 2 months 6.Participation in another interventional clinical trial for weight loss 7.Current or recent (within 3 months) treatment diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean absolute and percent change in body weight from baseline to follow-up (measured using digital weighing scale)Timepoint: Baseline to follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in BMI, waist-hip ratio, waist and hip circumference 2.Lean body mass, visceral fat, body fat %, skeletal muscle %, bone mass, metabolism, protein %, obesity degree %, body age (via BIA – Omron Karada Scan) 3.RAND 36-Item Health Survey 1.0 Questionnaire (SF-36) at baseline, week 4, week 8 4.Patient global satisfaction (0–3 scale) at week 8 5.Physician global satisfaction (0–3 scale) at week 8 6.Adherence and discontinuation 7.Adverse event reporting.Timepoint: Baseline to follow-up | — |
Countries
India
Contacts
CROM Clinical Research & Medical Tourism Pvt. Ltd.