Capsaicinoids effect on appetite response
| ISRCTN | ISRCTN16751129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16751129 |
| Secondary identifying numbers | CAPOL001_2015 |
- Submission date
- 16/12/2016
- Registration date
- 24/01/2017
- 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
Obesity is a growing problem worldwide, which puts people at risk of developing serious health problems such as diabetes and heart disease. Capsaicinoids are compounds which are found in peppers. The most common of which is capsicum, which is an important component of chili peppers. Studies have shown that consuming capsaicinoids may help boost metabolism, which could help people to lose weight. The aim of this study is to look at the effects on the body of taking capsaicinoid-containing supplements for a week with breakfast.
Who can participate?
Adults aged between 19 and 51 years who are overweight or obese.
What does the study involve?
All participants are given 100 mg Capsimax (which contains capsaicinoids) to take by mouth with their breakfast meal every day for one week. On the first and seventh day of the study, participants complete surveys in order to assess their lifestyle and appetite. In addition, their heart rate and blood pressure are also recorded.
What are the possible benefits and risks of participating?
There are no direct benefits or risked involved with participating.
Where is the study run from?
OmniActive Health Technologies Ltd. (India)
When is the study starting and how long is it expected to run for?
October 2016 to December 2018
Who is funding the study?
The University of Tampa (USA)
Who is the main contact?
1. Dr Vijaya Juturu (scientific)
2. Dr Jacob Wilson (scientific)
Contact information
Scientific
OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
07960
United States of America
 ORCID ID |
0000-0002-7397-715X |
|---|
Scientific
The University of Tampa’s exercise physiology laboratories
Human Performance Laboratories
Tampa
FL 33606
United States of America
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| 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 reduces appetite response: an open label study in free living population |
| Study objectives | The aim of this study is to examine the effects of capsaicinoids (CAPs) supplementation for a week on resting heart rate, diastolic and systolic blood pressure, willingness to exercise, duration and intensity of exercise, and appetite. |
| Ethics approval(s) | VJ University of Tampa, 10/06/2015, ref: 13-07 |
| Health condition(s) or problem(s) studied | Capsaicinoids supplementation |
| Intervention | Following provision of informed consent, all participants are given 100 mg Capsimax (which contains 2 mg capsaicinoids) to take with their breakfast meal for 7 days. On the first day of the study period, participants complete pre and general surveys on their life style, appetite measures as well as having their resting heart rate and blood pressure measurements recorded. On the final day (day 7), participants complete post survey questionnaires and have their resting heart rate and blood pressure recorded. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Appetite is measured using VAS questionnaires and subjective questionnaires at baseline and 7 days 2. Exercise habits are measured using surveys designed for the purpose of this study at baseline and 7 days |
| Secondary outcome measures | 1. Resting heart rate is measured manually by researchers at baseline and 7 days 2. Diastolic and systolic blood pressure is measured using a sphygmomanometer at baseline and 7 days |
| Overall study start date | 31/05/2015 |
| Completion date | 06/08/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Aged between 19-51 years 2. BMI of less than 40kg/m2 3. Provision of written informed consent |
| Key exclusion criteria | 1. Chronic disease/condition 2. Pregnancy or lactation 3. No dietary supplement consumption |
| Date of first enrolment | 15/06/2015 |
| Date of final enrolment | 30/07/2015 |
Locations
Countries of recruitment
- United States of America
Study participating centre
401 W. Kennedy Blvd.
Tampa
33606-1490
United States of America
Sponsor information
Industry
Cybertech House, First Floor
J.B. Sawant Road
Wagle Industrial Estate
Thane (West)
400 604
India
"ROR" |
https://ror.org/03fxrgb29 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/02/2017 | Yes | No |
Editorial Notes
31/07/2018: Publication reference added.
