Title of Project: The effects of sourdough on the gut microbiome and mood

Your Questions Answered

Name of Investigators: Dr.Mariasole Da Boit,  Vanessa Kimbell

We would like to invite you to participate in our research study. Before you decide whether to take part, we would like you to understand why the research is being done and what it would involve for you. One of our team will go through the information sheet with you and answer any questions you have, and also provide more details if requested. Please, feel free to discuss it with others if you wish to, and take time to decide whether you wish to take part or not.

What is the purpose of the study?

Sourdough is long slow fermented bread.  There are studies in vitro that show that the long slow fermentation of bread delivers more bioavailability of phenolics in the flour. This, in turn, may increase levels beneficial gut microbes, which have been associated in increases in SFFA production and having a positive effect on mood. Most of this information is limited because it is either in vitro (meaning in a mechanical gut) or it is early days in a new area of understanding the effect of food on our mood. Therefore, the aim of this study is to look at the effects of eating wholegrain yeasted bread, and wholegrain sourdough bread on changes in the gut microbiome and in mood in healthy adults. The current study is a research project for my master’s in nutrition & Digestibility of Bread.

What does the study involve?

The study involves slightly different things for each group of participants:

• Group 1  – The Sourdough group. This group will need to bake sourdough and eat 200g per day for 8 weeks
• Group 2  – The Yeasted bread. This group will need to bake yeasted bread and eat 200g per day for 8 weeks
• Group 3  – The control group. You will need to just maintain normal eating habits.

All groups will be asked to keep a mood score & food dairy

All groups will need to self-record weight.

Why have I been chosen?

We will recruit 16 non-smoking healthy students, within the De Montfort University student population, between the age 18+.

 Do I have to take part?

 Your participation is entirely voluntary, and you can withdraw from the study at any time, without giving a reason. If you decide to take part, you will be given this information sheet to keep for your records and be asked to sign a consent form.

I am interested in taking part, what do I do next?

If you are interested in taking part, please get in touch with [email protected] or phone 07707 480336 or Dr Mariasole Da Boit (e-mail address: [email protected], phone number 01162078137)

What if I agree to take part and then change my mind?

If you wish to withdraw from the study you can do this without giving a reason at any time. Any measurements collected will be deleted immediately upon request.

What is the procedure that is being tested?

Gut microbiome: this will be measured using a self-administered stool sample which you will need to return in the pre-paid box.

What are the possible disadvantages and risks of taking part?

• Participating in this type of study will require you to dedicate some of your time to it. you ill need to keep a food diary to record what you have eaten according to the requirements of your group and score your mood each day.
• Taking a stool sample may be slightly embarrassing for some people, but it is very similar to the kind of sample you might carry out medically for testing on the NHS and you will be provided with all the equipment and instructions needed to do this easily.

What are the possible benefits of taking part?

You will have access to a full gut microbial analysis which are indicators of your health status. Moreover, your participation will provide useful information which will be used to better understand the relationship between your food, your gut health and wellness.

You will also be given the opportunity to learn how to bake sourdough whichever part of the group you are with an online sourdough course and supporting materials. Either before or after your participation, depending on which group you are in.

What if something goes wrong?

If you are harmed by taking part in this research project, there are no special compensation arrangements.  If you are harmed due to someone’s negligence, then you may have grounds for legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal University complaints mechanisms should be available to you.”

 Who can I complain to?

If you have any concerns about any aspect of the study, you should approach the investigator Dr Mariasole Da Boit (e-mail address: [email protected], phone number 01162078137), who will do their best to answer any questions. Should you wish to discuss a complaint with someone who is not part of the research study team you may contact the Administrator for the Faculty Research Ethics Committee, Research & Commercial Office, Faculty of Health & Life Sciences, 3.35 Edith Murphy House, De Montfort University, The Gateway, Leicester, LE1 9BH or [email protected]

Will my taking part in this study be kept confidential? 

All information collected is necessary for the execution of the study. All information which is collected about you during the course of the research will be kept on a password-protected database and is strictly confidential. You will be given an ID code which will be used instead of your name. Any identifiable printed information you may give will be anonymised and stored in a locked filing cabinet in the office at The Sourdough School Ltd, NN69DQ. As per De Montfort University requirements, all raw and analysed data will be kept for 5 years.  Only the investigators will have access to your information collected during the 2 visits, however, members of the faculty human research ethics committee may require access to check that the study has been conducted in accordance with the approval.

What will happen to the results of the research study

The results of this study will be used by Vanessa Kimbell studying for a master’s in Nutrition and digestibility of Bread under the biomedical sciences department of De Montford University to write a research article, and you will not be identifiable from these reports. The researchers will be happy to give you a copy of your results and findings of the study.

Who is organising and funding the research?

De Montfort University is sponsoring this study & Atlas Biomed & Puratos Ltd

Who has reviewed the study

This study has been reviewed and approved by De Montfort University, Faculty of Health and Life Sciences Research Ethics Committee.

Contact for Further Information

If you require any further information or you would like to discuss the study with the investigators, please contact:

Vanessa Kimbell          E-mail address: [email protected] or phone 07707 480336

Dr Mariasole Da Boit    e-mail address: [email protected]

phone number 01162078137

Register Your Interest

 

 

                                THANK YOU FOR PARTICIPATING!