Affects of of consumption of capsaicinoids Nutritional, Metabolic, Endocrine
Conditions
Interventions
In a double blind, randomized, placebo controlled design seventy-seven (29.6 ± 11.3 y, 171.2 ± 9.8 cm, 80.9 ± 18.9 kg, 27.4 ± 5.4 kg/m2) apparently healthy males and females were randomly assigned by
Sponsors
OmniActive Health Technologies Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing to sign informed consent form 2. Male and Females aged 18-56 years, normal healthy individuals 3. BMI of 24.5-29.5 kg/m 4. Participant has not used any ergogenic aids within the previous 6 months of the start of the study 5. Participant is willing and able to comply with protocol 6. Participant is apparently healthy and free from disease, as determined by a health history questionnaire 7. Participant agrees to abstain from strenuous activity 24-48 hours prior to each testing visit 8. Participant agrees to be fasted for 12 hours prior to each testing visit 9. Participant agrees to refrain from smoking, caffeine, and tobacco for 12-hours prior to each testing visit 10. Participant agrees to abstain from consuming alcohol 24-hours before each testing visit 11. Participant has provided written and dated informed consent to participate in the study 12. Participant is currently not pregnant or does not plan to become pregnant during the duration of the study
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, lactating within 6 weeks before the study start and during study, or planning to become pregnant 3 months before or during the study 2. Post menopausal women on hormone replacement therapy (HRT) for less than 90 days prior to randomization 3. Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or more occasions or use of antihypertensive medications which may affect energy expenditure including alpha blockers, beta blockers, angiotensin receptor blockers or inhibitors of angiotensin converting enzyme 4. Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous drug use 5. Chronic ethanol use (> 3 drinks /day) 6. Endocrine disorders including hypo or hyperthyroidism (including subclinical disease), Cushings disease, growth hormone deficiency or other pituitary diseases 7. Chronic renal impairments (serum creatinine 180 mmol/liter), active liver disease; 8. Moderate to severe peripheral vascular disease 9. Severe chronic obstructive pulmonary disease, congestive heart failure (New York Heart Association 2), angina requiring nitrates 10. Use of other medications to treat obesity including medications obtained over the counter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), or phentermine (Adipex P) within the past 6 months 11. History of an eating disorder including anorexia or bulimia 12. History of surgery for the treatment of obesity (gastric banding, gastric bypass) 13. Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association guidelines 14. Have any known metabolic disorder including heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism 15. Have taken ergogenic levels of nutritional supplements that may affect muscle mass or aerobic capacity (e.g., creatine, HMB) or anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within 6 months prior to the start of the study 16. Have any absolute or relative contraindication for exercise testing or prescription as outlined by the American College of Sports Medicine 17. Report any unusual adverse events associated with this study that in consultation with the supervising physician recommends removal from the study 18. Have consumed any dietary supplements (excluding multivitamins, including herbal supplements for weight loss, or any other metabolic condition) 1 month prior to the study; 19. Have completed participation in any other clinical trial during the past 6 months; 20. Have a strong history of food or drug allergy of any kind 21. Any other condition in which principal investigator thinks may jeopardize the study; 22. Taking any satiety, diet or sport shake, powder or drink 23. Use of systemic corticosteroids such as oral/injectable hydrocortisonestable maintenance or low dose for >12 weeks 24. Use of statins (or any other medication for the treatment of hypercholesterolemia) such as atrovastatin (Lipitor), rosuvastatin (Crestor), simvastatin (Zocor), gemfibrozil (Lopid), etc 25. Any weight loss regimens, and intake of cholesterol lowering supplements such as fish oil capsules, phytoestrogens, soy lecithin or any polyphenols 26. Use of prescription antacids or anti-inflammatory medications on a regular basis. If acute intake, medication should not be used with 1 week of the test day 27. Use of drugs acting on the gut such as ezetimibe (Zetia), bile-acid binding resins and orlistat (Xenical) 28. Immunocompromised individuals such as subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Appetite and energy intake will be measured based on CNAQ and dietary intakes at baseline and at week 12 2. Body indices such as waist and hip circumference, measured at baseline and week 12 3. WHR and BMI, measured at measured at baseline and week 12 4. Body composition using DEXA, measured at baseline and week 12 5. Glucose, insulin and lipid profile, measured at baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (QoL), assessed using SF 36 Questionnaires at baseline and week 12 | — |
Countries
United States of America
Outcome results
None listed