Metabolic effects of mustard
| ISRCTN | ISRCTN19147515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19147515 |
| Secondary identifying numbers | Mustard1 |
- Submission date
- 03/07/2017
- Registration date
- 20/07/2017
- Last edited
- 07/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
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
Contact information
Dr Mirjam Langeveld
Scientific
Scientific
Academisch Medisch Centrum, F5-169
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| Study design | Randomised cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Metabolic effects of mustard allyl-isothiocyanate compared to placebo: a randomised cross over trial |
| Study objectives | 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(s) | Cambridge Central East of England Research Ethics Committee, 22/03/2012, ref: 6/Q0108/84 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 23/04/2012 |
| Completion date | 03/01/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key exclusion criteria | 1. Known medical conditions 2. Using medication or supplements likely to influence energy expenditure or other metabolic parameters |
| Date of first enrolment | 01/04/2012 |
| Date of final enrolment | 19/11/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Institute of Metabolic Science
Research organisation
Research organisation
Box 289
Addenbrooke’s Hospital
Cambridge
CB2 0QQ
United Kingdom
"ROR" |
https://ror.org/0264dxb48 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
BRC Seed Fund
No information available
FP7 People: Marie-Curie Actions
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- 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: Marie Skłodowska-Curie Actions, FP7-PEOPLE - Spezifisches Programm 'Menschen' zur Durchführung des Siebten Rahmenprogramms der Europäischen Gemeinschaft für Forschung, technologische Entwicklung und Demonstration (2007-2013), PEOPLE - Spezifisches Programm 'Menschen' zur Durchführung des Siebten Rahmenprogramms der Europäischen Gemeinschaft für Forschung, technologische Entwicklung und Demonstration (2007-2013), FP7 Spezifisches Programm 'Menschen' zur Durchführung des Siebten Rahmenprogramms der Europäischen Gemeinschaft für Forschung, technologische Entwicklung und Demonstration (2007-2013), Spezifisches Programm 'Menschen' zur Durchführung des Siebten Rahmenprogramms der Europäischen Gemeinschaft für Forschung, technologische Entwicklung und Demonstration (2007-2013), FP7 Spezifisches Programm 'Menschen', Spezifisches Programm 'Menschen', FP7-PEOPLE - Programa específico 'Personas' por el que se ejecuta el séptimo programa marco de la Comunidad Europea de acciones de investigación, desarrollo tecnológico y demostración (2007-2013), PEOPLE - Programa específico 'Personas' por el que se ejecuta el séptimo programa marco de la Comunidad Europea de acciones de investigación, desarrollo tecnológico y demostración (2007-2013), FP7- Programa específico 'Personas' por el que se ejecuta el séptimo programa marco de la Comunidad Europea de acciones de investigación, desarrollo tecnológico y demostración (2007-2013), Programa específico 'Personas' por el que se ejecuta el séptimo programa marco de la Comunidad Europea de acciones de investigación, desarrollo tecnológico y demostración (2007-2013), FP7 Programa específico 'Personas', Programa específico 'Personas', FP7-PEOPLE - Programme spécifique 'Personnes' mettant en œuvre le septième programme-cadre de la Communauté européenne pour des activités de recherche, de développement technologique et de démonstration (2007-2013), PEOPLE - Programme spécifique 'Personnes' mettant en œuvre le septième programme-cadre de la Communauté européenne pour des activités de recherche, de développement technologique et de démonstration (2007-2013), FP7 - Programme spécifique 'Personnes' mettant en œuvre le septième programme-cadre de la Communauté européenne pour des activités de recherche, de développement technologique et de démonstration (2007-2013), Programme spécifique 'Personnes' mettant en œuvre le septième programme-cadre de la Communauté européenne pour des activités de recherche, de développement technologique et de démonstration (2007-2013), FP7 rogramme spécifique 'Personnes', Programme spécifique 'Personnes', FP7-PEOPLE - Programma specifico 'Persone' che attua il settimo programma quadro della Comunità europea per le attività di ricerca, sviluppo tecnologico e dimostrazione (2007-2013), PEOPLE - Programma specifico 'Persone' che attua il settimo programma quadro della Comunità europea per le attività di ricerca, sviluppo tecnologico e dimostrazione (2007-2013), PF7 - Programma specifico 'Persone' che attua il settimo programma quadro della Comunità europea per le attività di ricerca, sviluppo tecnologico e dimostrazione (2007-2013), Programma specifico 'Persone' che attua il settimo programma quadro della Comunità europea per le attività di ricerca, sviluppo tecnologico e dimostrazione (2007-2013), PF7 Programma specifico 'Persone', FP7-PEOPLE - Program szczegółowego 'Ludzie', wdrażającego siódmy program ramowy Wspólnoty Europejskiej w zakresie badań, rozwoju technologicznego i demonstracji (2007–2013), PEOPLE - Program szczegółowego 'Ludzie', wdrażającego siódmy program ramowy Wspólnoty Europejskiej w zakresie badań, rozwoju technologicznego i demonstracji (2007–2013), PF7 Program szczegółowego 'Ludzie', wdrażającego siódmy program ramowy Wspólnoty Europejskiej w zakresie badań, rozwoju technologicznego i demonstracji (2007–2013), PF7 Program szczegółowego 'Ludzie', Program szczegółowego 'Ludzie', wdrażającego siódmy program ramowy Wspólnoty Europejskiej w zakresie badań, rozwoju technologicznego i demonstracji (2007–2013), Program szczegółowego 'Ludzie'
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Medical Research Council
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
British Heart Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Biotechnology and Biological Sciences Research Council
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The article describing the study results is currently submitted to a peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2017 | Yes | No |
Editorial Notes
07/08/2018: Publication reference added.
24/07/2017: Ethics approval information added.
