Plain English Summary
Background and study aims
Increasing energy use (energy expenditure) is a way for overweight or obese people to lose weight. Mustard’s pungent component AITC has the potential to increase energy expenditure and may have other beneficial effects on metabolism. The aim of this study is to investigate the effects of mustard on energy expenditure, glucose and fat utilization, body temperature, cold and hunger scores and blood values such as glucose.
Who can participate?
Healthy volunteers aged 18 to 65
What does the study involve?
Participants are studied on three different days. On each day they take either a spoon of mustard or capsulated mustard, or capsules with a placebo (dummy) mixture. At 30-minute intervals indirect calorimetry (a way to measure energy expenditure and fat and glucose utilization), cold/hunger scores and blood tests are performed. Temperature is measured continuously using a temperature monitoring pill. In between the measurements participants are allowed to read or watch TV but confined to bed. Blood samples are taken via an venous catheter (tube into a vein). Afterwards they eat a test meal during which appetite and food intake are measured.
What are the possible benefits and risks of participating?
There were no specific risks or benefits for the volunteers from participating in the study. Volunteers are reimbursed for travelling expenses and offered compensation for time spent participating.
Where is the study run from?
University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrooke’s Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2012 to January 2014
Who is funding the study?
The trial was funded by grants from the NIHR, BRC Seed Fund, Marie Curie Fellowships, Welcome Trust Fellowship, MRC, BHF and the BBSRC
Who is the main contact?
Dr M Langeveld
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Mustard1
Study information
Scientific title
Metabolic effects of mustard allyl-isothiocyanate compared to placebo: a randomised cross over trial
Acronym
Study hypothesis
Ingestion of mustard (containing the active ingrediënt allyl-isothiocyanate (AITC) ) induces thermogenesis (primary outcome) and alters body temperature, cold and hunger sensations, plasma metabolic parameters and energy intake (secondary outcomes).
Ethics approval
Cambridge Central East of England Research Ethics Committee, 22/03/2012, ref: 6/Q0108/84
Study design
Randomised cross over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Overweight, obesity
Intervention
In this study with a crossover design, 10 healthy subjects were studied under temperature controlled conditions after an overnight fast. After the ingestion of capsulated mustard (10 grams) or unpackaged mustard (10 grams) or capsulated placebo mixture, measurements of energy expenditure, substrate oxidation, core temperature, cold and hunger scores and plasma parameters were repeated every 30 minutes during 150 minutes. Randomisation was done by flipping a coin by the investigator to decide between the administration of capsulated mustard or the administration of capsulated placebo mixture. Unpackaged mustard was given as final intervention since participants could not be blinded to this intervention. After the experiments were performed, energy intake was measured in a test meal using the universal eating monitor.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Energy expenditure (thermogenesis), measured using by indirect calorimetry using a ventilated canopy respiratory gas exchange (GEM; GEMNutrition, Daresbury, UK) at baseline and 30, 60, 90, 120 and 150 minutes after the intervention
Secondary outcome measures
Measured at baseline and 30, 60, 90, 120 and 150 minutes after the intervention:
1. Core body temperature, measured using a temperature pill (VitalSense, Respironics, Bend, OR, USA)
2. Cold and hunger sensations, determined by asking the participant to rate the sensation of cold of the whole body and hands separately on a 1 to 10 scale, with ratings as following; 1 was rated as not at all cold and 10 was the coldest one had ever felt. Similarly for the degree of hunger, with ratings as: 1 for not hungry at all, and 10 was rated as the most hungry one had ever felt
3. Plasma metabolic parameters; blood samples taken via an indwelling venous catheter
3.1. Glucose measured using the Hexokinase method on a Siemens Dimension RXL AutoAnalyser, reagents and calibrators purchased from Siemens
3.2. Non-esterified free fatty acids (NEFAs) measured using the Roche Free Fatty Acid kit
3.3. Free thyroxin (fT4) measured by time-resolved fluorescence immunoassay on an AutoDELFIA analyser (Perkin Elmer) using kits from Perkin Elmer
3.4. Cortisol measured by fluorescence immunoassay on the Siemens Centaur Autoanalyser
4. Energy intake determined by using the Universal Eating Monitors (UEM)(The Sussex Meal Patterning System) during the test meal at 160 minutes after the intervention. Subjects ate a homogenous test meal (e.g. pasta) containing normal energy percent ratios (~30% carbohydrates, ~30% protein and ~40% fat). Test meal intake continuously monitored using the UEM equipment
Overall trial start date
23/04/2012
Overall trial end date
03/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy volunteers
2. Men and women
3. Non-smokers
4. Age between 17 and 65 years
5. No known medical conditions
6. Not taking any medications or supplements likely to influence energy expenditure
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Known medical conditions
2. Using medication or supplements likely to influence energy expenditure or other metabolic parameters
Recruitment start date
01/04/2012
Recruitment end date
19/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
BRC Seed Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
FP7 People: Marie-Curie Actions
Alternative name(s)
FP7-PEOPLE - Specific Programme "People" Implementing the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (2007 to 2013), PEOPLE - Specific Programme "People" Implementing the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (2007 to 2013), FP7 Specific Programme "People" Implementing the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (2007 to 2013), Specific Programme "People" Implementing the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (2007 to 2013), FP7 Specific Programme "People", Specific Programme "People", FP7-PEOPLE, FP7 People, FP7 People: Marie Skłodowska-Curie Actions, PEOPLE
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Funder name
Biotechnology and Biological Sciences Research Council
Alternative name(s)
BBSRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The article describing the study results is currently submitted to a peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as this was not outlined in the original study set up and application to the medical ethics committee. The original data will be held at the University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrookes Hospital.
Intention to publish date
01/10/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary