Not Applicable Not Applicable
Conditions
Interventions
Participants will be randomly assigned to ingest Salacia extract at dosages of 200 mg SCE , 300 mg SCE and 500 mg SCE (OmniLeanTM) or placebo (PLA) in a single-center, double-blind, randomized, place
Sponsors
OmniActive Health Technologies Ltd (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18-55 years of age (both ages inclusive), of BMI 24.5 to 29.5 Kg/ m2 2. Participants required to avoid all dietary supplements, OTC or any foods interfere with post-prandial glucose and insulin before and throughout the study period and not allowed to drink alcoholic beverages or caffeine during the period of the study 3. Non smokers 4. No pregnant and lactating women 5. Signed consent form
Exclusion criteria
Exclusion criteria: 1. Participation in any bioavailability/bioequivalence/pharmacokinetic study or received an investigational drug within a period of 3 calendar months prior to check in of period one 2. Use of dietary supplements to reduce body weight or metabolic health management at least 30 days before check in of period one 3. Use of hormone replacement therapy for a period of 6 calendar months prior to check in of period one 4. History of drug abuse, or alcohol dependence or abuse 5. History of any allergies (asthma, urticaria) including drug allergies 6. Known hypersensitivity or allergy to Salacia extract or any of the excipients or related drugs. 7. Smokers, prescriptions, chronic conditions such as hypertension, diabetes , inflammatory disorders, cardiovascular disease and cancer etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose and insulin responses after 0, 30, 60, 90, 120 and 180 min | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC glucose and AUC insulin | — |
Countries
India
Outcome results
None listed