Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/12/2016
Date assigned
15/12/2016
Last edited
15/12/2016
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. The main reason that people become obese is thought to be due to over-eating and/or not exercising enough. It has also been found that some people with obesity have a lower metabolism than healthy people. Capsaicinoids are a type of chemical which are found in members of the capsicum family of plants (chilies). There is evidence to suggest that capsaicinoids may play a role in metabolism (the breakdown of food and drink into energy). The aim of this study is to look at the effect of capsaicinoids on metabolism for weight management.

Who can participate?
Healthy adults who have a sedentary or lightly active lifestyle.

What does the study involve?
Participants are randomly allocated to one of two group who receive two treatments in a random order, with one week of no treatment in between. The first treatment involved receiving 100mg Capsimax (Capsaicinoids 2 mg) with a meal. The second treatment involves receiving a placebo (dummy drug) with a meal. Before and then 1, 2 and 3 hours after consuming the meal, participants have their metabolic rate calculated using specialized equipment and their heart rate measured. In addition, participants are asked to rate their appetite and interest in eating after 3 hours.

What are the possible benefits and risks of participating?
Participants benefit from learning about their own energy expenditure (metabolism). There are no known risks involved with participating.

Where is the study run from?
Arizona State University (USA)

When is the study starting and how long is it expected to run for?
January 2016 to March 2017

Who is funding the study?
OmniActive Health Technologies Ltd. (India)

Who is the main contact?
Dr Vijaya Juturu
v.juturu@omniactives.com

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
67 East Park Place
Suite 500
Morristown
07960
United States of America
+91 90 84776953
v.juturu@omniactives.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STUDY00004264

Study information

Scientific title

Capsaicinoids Enhance Metabolic Rate Using a Novel Metabolic Tracker Breezing Device – An Open Label Study

Acronym

Study hypothesis

The digestion of the meal induce energy expenditure processes that produces heat, increases heart rate due to higher blood circulation, and increases oxygen consumption and carbon dioxide production. The latter is measured via breath analysis and a measurement named metabolic rate or energy expenditure.

Ethics approval

Arizona State University- Enterprise and Development IRB, 28/04/2016

Study design

Single blind acute placebo-controlled crossover open label study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Metabolism

Intervention

Participants are randomised to one of two groups who receive two treatments in a random order.

Group 1: Participants receive 100 mg Capsimax (Capsaicinoids 2 mg) once a day with a meal single administration..
Group 2: Participants receive a placebo (corn starch) once a day with a meal single administration.

After each treatment period, participants undergo one week wash-out before starting the other treatment.

The Breezing® device evaluates people’s energy expenditure (EE) by detecting the rate of oxygen consumption and carbon dioxide generation in breath. It is based on a flow meter for flow detection and a chemical sensing cartridge, which used a cell-phone camera for optical detection. The device is 6.0 oz. (170 g), and 1.8 in × 2.1 in × 4.8 in (4.7 cm × 5.4 cm × 12.3 cm), and connects wirelessly to an iOS/Android mobile device, via Bluetooth®. A QR code with pre-calibrated sensor information is applied on the single-use sensor cartridge, which can be scanned and recognized by the mobile application.
During each measurement, participants breathed through a disposable mouthpiece connected to the Breezing® device for about 1-2 minutes until a total of 6L exhaled breath were measured by the flow meter. The data received on the mobile device is processed and displayed on the application. According to Weir equation, RQ, VO2 and VCO2, the energy expenditure is determined. The participants will be provided with meal including a non-caloric, decaf drink and certain amount of Thomas Plain Bagel and 1/3 less fat Philadelphia cream cheese based on their REE level. The ratio of calorie intake to their REE value was 0.35 for 14 participants and 0.25 for 25 participants. In the meantime, the participants will be served with either a Capsaicinoids pill or a placebo pill. After finishing the meal/pill, the participants’ metabolic rate will be measured at 1, 2, and 3 hours .

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Resting Energy Expenditure (Metabolic rate) is measured using breezing equipment (indirect calorimetry) at baseline, 1 hour, 2 hours and 3 hours and data calculated for 24 hours (overall average ∆REE%).

∆REE: REEi – REE0
∆REE (%) : [(REEi – REE0)/REE0] *100%

Secondary outcome measures

1. Heart rate measured using i-phone apps and blood pressure are measured using with sphygmomanometer at baseline and after 3 hours
2. Appetite and interest on food intake is measured using a visual analogue scale (0-100 scale) at baseline and at 3 hours

Overall trial start date

01/05/2016

Overall trial end date

15/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. English-speaking
2. Adult participants (18 – 80 years old)
3. Sedentary or lightly active lifestyle
4. Able to consent and perform the necessary tests for the study

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

40 subjects Crossover trial

Participant exclusion criteria

1. Food allergy or sensitive to gluten
2. Under treatment for chronic conditions/disease such as cancer, burns or obstructive pulmonary diseases

Recruitment start date

10/05/2016

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

Arizona State University
Center of Bioelectronics and Biosensors Biodesign Institute
Tempe AZ
85281
United States of America

Sponsor information

Organisation

OmniActive Health Technologies Ltd.

Sponsor details

OmniActive Health Technologies
Phoenix House
T- 8
A Wing
462 Senapati Bapat Marg
Lower Parel
Mumbai
400 013
India

Sponsor type

Industry

Website

http://omniactives.com/

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 high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Erica Forzani (eforzani@asu.edu) or Dr Vijaya Jutruu (v.juturu@omniactives.com).

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes