Tolerability and safety of capsaicinoids from capsicum extract (Capsimax®)
| ISRCTN | ISRCTN10975080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10975080 |
| Secondary identifying numbers | OMNI1000 (Tolerability Phase) |
- Submission date
- 02/06/2015
- Registration date
- 08/06/2015
- Last edited
- 31/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Capsaicinoids are an active component of chilli peppers. They have been well researched and a number of clinical studies have suggested that they have health benefits. However, a person would have to consume 10g red hot peppers every day to gain any of these benefits. Capsimax™ is a supplement that contains capsaicinoids in beadlet form. This study will test how safe and tolerable Capsimax™ is when taken by healthy women compared with a placebo.
Who can participate?
Healthy women aged between 25 and 55.
What does the study involve?
The participants are randomly allocated to one of two groups. Those in group 1 (intervention) are given Capsimax™ supplemented with increasing levels of capsaicinoids every week for 5 weeks. For week 1, the capsaicinoids dose is 2mg, week 2, 4mg, week 3, 6mg, week 4, 8mg and, finally, week 5, 10mg. Participants in group 2 (control) are given a placebo for 5 weeks.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Medicus Research CRO, Staywell Research Clinical Research Site, California (USA)
When is the study starting and how long is it expected to run for?
July 2011 to October 2011
Who is funding the study?
OmniActive Health Technologies Inc (USA)
Who is the main contact?
Dr Vijaya Juturu
Contact information
Scientific
67 East Park Place
Morristown
07960
United States of America
 ORCID ID |
0000-0002-7397-715X |
|---|
Study information
| Study design | Randomized double-blind placebo-controlled dose-finding adaptive design study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Tolerability and safety of capsaicinoids from capsicum extract (Capsimax®): a randomized, double-blind, placebo-controlled, dose-finding, adaptive-design study |
| Study objectives | The purpose of this study was to evaluate the tolerability and impact on metabolic measures of escalating doses of the Capsimax™ product for over 5-week period. |
| Ethics approval(s) | Copernicus Group Independent Review Board (Cary, NC), 13/01/2011 |
| Health condition(s) or problem(s) studied | Tolerability and dose testing |
| Intervention | 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) Week 2 – initiation of dose level 3 (4mg) Week 3 – initiation of dose level 4 (6mg) Week 4 – initiation of dose level 5 (8mg) Week 5 – initiation of dose level 6 (10mg) Week 6 – end of study 2. Group 2 (control) given a placebo for 5 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Tolerability assessments and adverse event reporting 1. Weight 2. BMI 3. Blood Pressure |
| Secondary outcome measures | 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 |
| Overall study start date | 22/07/2011 |
| Completion date | 12/10/2011 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Tolerability Sub-Study 12 Subjects were enrolled in the tolerability phase of the study |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/07/2011 |
| Date of final enrolment | 12/10/2011 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Northridge
California
91325
United States of America
Sponsor information
Industry
67 East Park Place
Suite 500
Morristown
07960
United States of America
| Website | http://www.omniactives.com/ |
|---|---|
"ROR" |
https://ror.org/024e1pj18 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No |
Editorial Notes
31/07/2018: Internal review.
23/02/2016: Publication reference added.
