None listed
Conditions
Interventions
Intervention1: LI85008F 900mg/Day: 2 capsules to be taken daily in the morning after breakfast for 7 days
Control Intervention1: Placebo: 2 capsules to be taken daily in the morning after breakfast f
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male and female subjects aged between 20 and 39 years with body mass index (BMI) of 25 to 29.9 kg/m2. Subjects with sedentary lifestyle, no regular athletic or sports activities. Normal thyroid hormone profile. Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks & chocolate for at least 24 hr prior to randomization day. Subjects who are non smokers. Subject agrees to maintain diet tracker. Subject considered generally healthy as per health history and routine clinical investigations during screening. Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit. Ability to understand the risks or benefits of the protocol and willing to sign the written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who were taking medications which affect the resting metabolic rate (RMR) (e.g. antidepressants, beta-blockers, hormones, etc.). Subjects who lost or gained greater than 3kg body weight in past 3 months. Subjects who are diabetic and or hypertensive. Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. Subjects taking medications for or suffering from a medical condition that could impact results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer). Subjects with HIV Positive. Female subjects who are pregnant, breast feeding or planning to become pregnant during the study. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures. Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or ergogenic aids and thermogenics within 30 days prior to the study. Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Resting metabolic rate (RMR) Timepoint: Day 1 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure (Systolic ,Diastolic)Timepoint: Screening visit, Day 1 and 7;Free fatty acid in serumTimepoint: Day 1 and 7;Heart rateTimepoint: Screening visit, Day 1 and 7;POMS-SF QuestionnaireTimepoint: Screening visit, Day 1 and 7 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar
Laila Nutraceuticals
Outcome results
None listed