Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information



Primary contact

Dr Vijaya Juturu


Contact details

67 East Park Place
Suite 500
United States of America

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Capsaicinoids supplementation reduces appetite and body circumferences in healthy men and women: a placebo controlled randomized double blind study


Study hypothesis

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

Institutional Review Board (IRB) at the University of Mary Hardin-Baylor, 09/05/2015

Study design

Double blind randomized placebo controlled design

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Affects of of consumption of capsaicinoids


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



Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant 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
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
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

Participant type

Healthy volunteer

Age group




Target number of participants


Participant 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
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

Recruitment start date


Recruitment end date



Countries of recruitment

United States of America

Trial participating centre

University of Mary Hardin-Baylor
900 College St, Belton
TX 76513
United States of America

Sponsor information


OmniActive Health Technologies Inc

Sponsor details

67 East Park Place
Suite 500
United States of America

Sponsor type




Funder type


Funder name

OmniActive Health Technologies Ltd (Mumbai India)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary


Publication citations

Additional files

Editorial Notes