Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/07/2017
Date assigned
20/07/2017
Last edited
24/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mirjam Langeveld

ORCID ID

Contact details

Academisch Medisch Centrum
F5-169
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

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

Sponsor information

Organisation

Institute of Metabolic Science

Sponsor details

Box 289
Addenbrooke’s Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes

24/07/2017: Ethics approval information added.