Prevention of obesity in overweight women Nutritional, Metabolic, Endocrine
Conditions
Interventions
Product to be tested:
- Test group: LIPOXIM FIRE capsule
- Reference group: Placebo capsule
Amount : LIPOXIM FIRE, 2 capsules each before the 2 main mea
Sponsors
INNOVATION LABO
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy non-smoker Asian or Caucasian female subjects between 25 to 60 years (inclusive) of age 2. Subject with BMI range of 25 - 29.9 kg/m² (both inclusive) 3. Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies 4. Subject agrees not to start any new therapies for weight loss during the course of the study 5. Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 6. Willing to give written informed consent and willing to comply with the trial protocol 7. Ability to understand the risks/benefits of the protocol 8. Subject should be available for the duration of the study period (2 months)
Exclusion criteria
Exclusion criteria: 1. Subjects suffered from intractable obesity and had experienced recent unexplained weight loss or gain 2. Subject taking any over the counter weight loss agents, centrally acting appetite suppressants 3. Pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader Willi syndrome and thyroid disease) 4. Subject with a history of anorexia nervosa 5. Subject with prior any surgical therapy for obesity 6. Subject with diabetes, dyslipidemia, hypertension, cardiovascular disease and any other co-morbidity and considered as not healthy 7. Subjects on prolonged (greater than 6 weeks) product with corticosteroids, antidepressants, anticholinergics, antipsychotic drug etc. or any other drugs that may have an influence on the outcome of the study 8. Subjects suffering from major systemic illness necessitating long term drug product intake 9. Alcoholics and/or drug abusers 10. History of hypersensitivity to curcumin and wakame extract or any component of XTRA SLIM 700 formula 11. Pregnant/lactating woman 12. Subjects using other modulators like diet control, gym and yoga and wish to continue even after enrollment 13. Subjects having a history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 14. Subjects who have completed participation in any other clinical trial during the past 3 months 15. Any other condition which the Principal Investigator thinks may jeopardize the study outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body weight, body fat, lean mass, water mass and body mass index (BMI) at day 0, 15, 30, 45, 60 using InBody 720, (BioSpace Co. Ltd., Seoul, Korea) 2. Waist circumference, hip circumference, thigh circumference and waist/hip ratio at day 0, 15, 30, 45, 60 3. Self-evaluation questionnaire at day 30 and 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneously reported and observed adverse events after first dose until end of product intake visit | — |
Countries
Japan
Outcome results
None listed