Capsaicinoids supplementation effect on appetite and body composition in healthy men and wome
- Conditions
- Affects of of consumption of capsaicinoidsNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN10458693
- Lead Sponsor
- OmniActive Health Technologies Inc
- Brief Summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28235621 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30123516
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Appetite and energy intake will be measured based on CNAQ and dietary intakes at baseline and at week 12<br>2. Body indices such as waist and hip circumference, measured at baseline and week 12<br>3. WHR and BMI, measured at measured at baseline and week 12<br>4. Body composition using DEXA, measured at baseline and week 12<br>5. Glucose, insulin and lipid profile, measured at baseline and week 12
- Secondary Outcome Measures
Name Time Method Quality of life (QoL), assessed using SF 36 Questionnaires at baseline and week 12