Capsaicinoids supplementation effect on appetite and body composition in healthy men and women
| ISRCTN | ISRCTN10458693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10458693 |
| Secondary identifying numbers | UMHB_OAHT009 |
- Submission date
- 13/04/2016
- Registration date
- 20/04/2016
- Last edited
- 21/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Background and study aims
There is evidence to suggest that capsaicinoids (CAP), substances found in the white pulp of chili peppers that gives them “heat” may have a number of health benefits, including helping weight loss and having anti-inflammatory and antioxidant effects. Studies have shown that CAP may help people to lose weight by, for example, stopping so many calories from being absorbed in the gut, reducing body fat and increasing metabolism. The aim of this study is to see whether taking a capsaicin supplement can affect a person’s appetite and body size a period of 12 weeks, comparing the effects of two different doses.
Who can participate?
Healthy adults aged between 18-56 and with a BMI of between 24.5-29.5 kg/m
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given 2mg CAP to take for 12 weeks. Those in group 2 are given 4mg CAP to take over 12 weeks. Those in group 3 are given a placebo (dummy) pill to take over 12 weeks. All participants are asked not to make any changes to their current levels of physical activity, restrict their intake of spicy foods and maintain their usual caloric intake from their diet. Each participants appetite and energy (food) intake, body measurements, BMI, glucose, insulin and fat levels and also their quality of life is assessed at the start of the study and again at the end.
What are the possible benefits and risks of participating?
This study may help participants to learn about their appetite and metabolic health and how they may be affected by taking capsaicinoids. This study may help them to understand how taking capsaicinoid supplements can be useful for weight management. There is no risk in taking part in the study.
Where is the study run from?
University of Mary Hardin-Baylor (USA)
When is the study starting and how long is it expected to run for?
June 2015 to December 2015
Who is funding the study?
OmniActive Health Technologies Ltd
Who is the main contact?
Dr Vijaya Juturu
Contact information
Dr Vijaya Juturu
Scientific
Scientific
67 East Park Place
Suite 500
Morristown
07960
United States of America
 ORCID ID |
0000-0002-7397-715X |
|---|
Study information
| Study design | Double blind randomized placebo controlled design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Capsaicinoids supplementation reduces appetite and body circumferences in healthy men and women: a placebo controlled randomized double blind study |
| Study objectives | Consumption of capsaicinoids (CAP), the bioactive and pungent principles in red hot pepper, has been shown to increase energy expenditure and may impact overall metabolism. In vivo studies suggest that supplementation of CAP could positively affect risk factors of cardiovascular health. Therefore, the purpose of this study was to examine the effects of two different doses of CAP on appetite and body circumference in healthy men and women. |
| Ethics approval(s) | Institutional Review Board (IRB) at the University of Mary Hardin-Baylor, 09/05/2015 |
| Health condition(s) or problem(s) studied | Affects of of consumption of capsaicinoids |
| Intervention | 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 fat mass to ingest either CAP (2mg CAP, CX1 or 4mg CAP, CX2 [CX, Capsimax®, OmniActive Health Technologies Ltd.]) or placebo (corn starch, PLA) for 12 weeks. Subjects were requested not to make any changes to their current physical activity, provided instructions to restrict spicy foods and maintain current caloric intake. Subjects were instructed to take the pills with 8 ounces of water after breakfast. At baseline (T1), 6 weeks (T2) and 12 weeks (T3), waist and hip circumferences, waist: hip ratio (WC, HC, and WHR), weight, appetite levels via Council on Nutrition appetite questionnaire (CNAQ) and adverse events questionnaires were administered. At baseline (T1) and 12 weeks (T3) complete blood count and complete metabolic panels were assessed. Statistical analyses utilized a two-way ANOVA (group x time) with repeated measures for all dependent variables (p < 0.05). |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | Quality of life (QoL), assessed using SF 36 Questionnaires at baseline and week 12 |
| Overall study start date | 15/06/2015 |
| Completion date | 30/12/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 56 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV) and treatment related infectious diseases or disorders 29. History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia; 30. Use of natural health products other than products containing vitamins or minerals as the sole medicinal except vitamin E or niacin (vitamin B3), 4 weeks prior to randomization and during the course of the trial 31. Past cardiac surgery or any surgical treatments for chronic diseases or planned surgery during the trial 32. History of diabetes, stroke, cardiovascular disease, cancer (except for successfully treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer), myocardial infarction, mental health disorders, GI disorders and infectious diseases 33. Uncontrolled hypertension defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with or without treatment 34. Alcohol consumption > 2 standard alcoholic drinks per day 35. Red wine consumption except when subject agrees to refrain during the study period 36. Current (or history of) significant confounding illness, allergy, substance abuse or condition that would prohibit participation 37. Allergy or sensitivity to study supplement ingredients 38. Spices in diets – please list products to avoid during study period or limit 39. Individuals who are cognitively impaired and/or who are unable to give informed consent 40. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject 41. Use of any dietary supplement for weight loss or weight management 42. Avoid capsiate /capsaicin/capsaicinoid supplements during the period of study 43. Minimize intake of hot chilli or hot peppers from different cuisines from Asia, China and Mexico, sauces, condiments, meals, pickles etc. [Specify sources of intake and record the data]. If possible avoid during the study period 44. Minimize spices and condiments such as black pepper, ginger, mustard etc. (record all sources and intake) 45. Use of prescriptions for weight management and weight loss 46. Use of diets for weight regimen or weight loss or weight management 47. No change in their daily activities |
| Date of first enrolment | 20/06/2015 |
| Date of final enrolment | 30/07/2015 |
Locations
Countries of recruitment
- United States of America
Study participating centre
University of Mary Hardin-Baylor
900 College St, Belton
TX 76513
76513
United States of America
TX 76513
76513
United States of America
Sponsor information
OmniActive Health Technologies Inc
Industry
Industry
67 East Park Place
Suite 500
Morristown
07960
United States of America
"ROR" |
https://ror.org/024e1pj18 |
|---|
Funders
Funder type
Industry
OmniActive Health Technologies
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2017 | Yes | No | |
| Results article | results | 13/08/2018 | Yes | No |
Editorial Notes
21/08/2018: Publication reference added.
31/07/2018: Publication reference added.
17/07/2018: The intention to publish date has been changed from 30/12/2016 to 30/12/2018.
25/09/2017: Internal review.
