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
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



Primary contact

Dr Vijaya Juturu


Contact details

67 East Park Place
United States of America

Additional identifiers

EudraCT number 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


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


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


Tolerability and dose testing


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



Drug names

Primary outcome measures

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
7. Glycerol
8. Free Fatty Acids
9. HbA1c

Overall trial start date


Overall trial end date


Reason abandoned


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




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


Recruitment end date



Countries of recruitment

United States of America

Trial participating centre

Medicus Research CRO
Staywell Research Clinical Research Site Northridge
United States of America

Sponsor information


OmniActive Health Technologies Inc. (USA)

Sponsor details

67 East Park Place
Suite 500
United States of America

Sponsor type




Funder type


Funder name

OmniActive Health Technologies Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in:

Publication citations

Additional files

Editorial Notes

23/02/2016: Publication reference added.