Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Vijaya Juturu
ORCID ID
http://orcid.org/0000-0002-7397-715X
Contact details
67 East Park Place
Morristown
07960
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OMNI1000 (Tolerability Phase)
Study information
Scientific title
Tolerability and safety of capsaicinoids from capsicum extract (Capsimax®): a randomized, double-blind, placebo-controlled, dose-finding, adaptive-design study
Acronym
Study hypothesis
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
Copernicus Group Independent Review Board (Cary, NC), 13/01/2011
Study design
Randomized double-blind placebo-controlled dose-finding adaptive design study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
22/07/2011
Overall trial end date
12/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
Tolerability Sub-Study 12 Subjects were enrolled in the tolerability phase of the study
Participant 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
Recruitment start date
22/07/2011
Recruitment end date
12/10/2011
Locations
Countries of recruitment
United States of America
Trial participating centre
Medicus Research CRO
Staywell Research Clinical Research Site
Northridge
California
91325
United States of America
Sponsor information
Organisation
OmniActive Health Technologies Inc. (USA)
Sponsor details
67 East Park Place
Suite 500
Morristown
07960
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
OmniActive Health Technologies
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
30/12/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27066073