Tolerability and dose testing Nutritional, Metabolic, Endocrine
Conditions
Interventions
Two randomly allocated groups:
1. Group 1 (intervention) given Capsimax™ supplemented with increasing levels of capsaicinoids every week for 5 weeks.
Week 1 – initiation of dose level 2 (2mg)
Wee
Sponsors
OmniActive Health Technologies Inc. (USA)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects between 25 and 55 years of age 2. Body mass index (BMI) between 25 and 34.9 kg/m2 (inclusive) 3. Judged by the Investigator to be in general good health on the basis of medical history 4. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator 5. Subject agrees to all study visits and procedures 6. Subject agrees to travel to DEXA facility location 7. Sedentary lifestyle: not being physically active greater than 3 days/week for 20 minutes each time for the previous 6 months, and not participating in regular resistance exercise
Exclusion criteria
Exclusion criteria: 1. Regular ingestion of chili peppers (raw or powdered form), black pepper, or ginger, or foods known to contain chili peppers, black pepper or ginger more than 3 times per week on average 2. Known allergy to chili pepper 3. Known allergy to any foods 4. Consumption of >3 servings per day of caffeine containing beverages 5. Any significant GI condition that would potentially interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Crohn’s), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance. 6. Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder 7. History or presence of cancer in the prior two years, except for non-melanoma skin cancer 8. Recent history of (within 12 months) or strong potential for alcohol or substance abuse 9. Participation in a clinical study with exposure to any non-registered drug product within 30 days prior 10. Individual has a condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk 11. Diabetes requiring medication 12. Untreated or unstable Hypothyroidism 13. Weight loss or gain of at least 10 pounds in the last 3 months 14. Participation in a formal weight loss program or diet plan in the last 3 months 15. Clinically significant abnormal Physical Examination 16. Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders 17. Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, Parkinson disease 18. Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study 19. Currently taking antacids or acid-blocking medications 20. Currently taking anti-coagulant medications (including but not limited to aspirin, ticlid, heparin, and Coumadin) 21. Currently taking MAO-Inhibitors 22. Currently taking herbal products or dietary supplements – subjects who are willing to wash out of these products may be included after a 2 week washout period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability assessments and adverse event reporting 1. Weight 2. BMI 3. Blood Pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CBC 2. CMP 3. Fasting insulin 4. Cholesterol Panel (Total Cholesterol, LDL, HDL, TG) 5. C-Peptide 6. HS-CRP 7. Glycerol 8. Free Fatty Acids 9. HbA1c | — |
Countries
United States of America
Outcome results
None listed