Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2016
Date assigned
24/01/2017
Last edited
25/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

http://orcid.org/0000-0002-7397-715X

Contact details

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
07960
United States of America

Type

Scientific

Additional contact

Dr Jacob Wilson

ORCID ID

Contact details

The University of Tampa’s exercise physiology laboratories
Human Performance Laboratories
Tampa
FL 33606
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAPOL001_2015

Study information

Scientific title

Capsaicinoids reduces appetite response: An open label study in free living population

Acronym

Study hypothesis

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

VJ University of Tampa, 10/06/2015, ref: 13-07

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

31/05/2015

Overall trial end date

06/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 19-51 years
2. BMI of less than 40kg/m2
3. Provision of written informed consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Chronic disease/condition
2. Pregnancy or lactation
3. No dietary supplement consumption

Recruitment start date

15/06/2015

Recruitment end date

30/07/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

The University of Tampa
Department of Health Sciences and Human Performance 401 W. Kennedy Blvd.
Tampa
33606-1490
United States of America

Sponsor information

Organisation

OmniActive Health Technologies Ltd.

Sponsor details

Cybertech House
First Floor
J.B. Sawant Road
Wagle Industrial Estate
Thane (West)
400 604
India

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

OmniActive Health Technologies Ltd.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

31/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes