What is the aim of this research?
The aim of the research is to investigate the effects of a bioactive seaweed supplement and a diet rich in Mediterranean diet components on gut health, immunity and metabolic markers in individuals aged between 18-65 years who are defined as pre-diabetics and adults in general good health.
Who can take part?
Inclusion criteria - If the following applies to you, you will be considered for participation in the sudy:
The study will be performed at Whitelands College campus of the University of Roehampton – the postal code is SW15 4JD. Upon arrival at the campus please make your way to the main reception – you will be met here. If you are driving to campus, please make sure that you know your car’s registration number so that we can record it with security.
General information:
The aim of the research is to investigate the effects of a bioactive seaweed supplement and a diet rich in Mediterranean diet components on gut health, immunity and metabolic markers in individuals aged between 18-65 years who are defined as pre-diabetics and adults in general good health.
Who can take part?
Inclusion criteria - If the following applies to you, you will be considered for participation in the sudy:
- Adults aged between 18 and 60 years, with
- Fasting blood glucose level of 5.6–6.9mmol/L or impaired HbA1c (HbA1c level of 5.7%–6.4%)
- Fasting blood glucose level below 5.6 mmol/L or HbA1c level below 5.7%
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
- People with a current diagnosis or clinical history of T2DM
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems.
- People who are already participating in a weight loss programme
- People receiving drug treatment for pre-diabetes (eg, metformin)
- People with a history of long-term use of medicines known to influence glucose metabolism (eg, corticosteroids)
- People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
- People who take antibiotics or bacterial agents (Probiotics) within 1 month
- Pregnant women, women ready for pregnancy, and nursing mothers
- Fill out a health screening questionnaire which consists of a brief medical history that will determine your eligibility in the study and take approximately 10 minutes.
- Provide an informed consent which ensures that you understand what the study is about and agree to taking part.
- Once you consent and pass the initial screening, your blood pressure, height, weight and body fat will be measured. You will be asked to give a fasting blood sample which will be used to screen some parameters that we are interested in and that are known to be good predictors of the risk of developing T2DM.
- If you meet all the inclusion criteria, you will then be randomly assigned a volunteer number and placed in one of three study group for a total of 16 weeks:
- Normal Healthy Diet group (N=15): Participants in general good health will be following the Eatwell booklet adviceand NICE/NHS guidelines
- Placebo group (N=15): Participants with prediabetes will take 2 capsules/day (750mg Maltodextrin placebo) before each of the two main meals without any advice on the diet to follow.
- Seaweed Group (N=15): Participants with prediabetes will take 2 seaweeds brown extract capsules/day (total dose of 700 mg) before each of the two main meals without any advice on the diet to follow.
- You will remain in the study for another 4 weeks but you will not be asked to consume any treatment (washout period).
- At baseline (week 0), week 6, week 12 and week 16, you will be required to visit the University of Roehampton in order to provide fasted blood, saliva, stool and first pass urine samples and have blood pressure, body fat and weight measured.Each visit will not take more than 60 minutes.
- During the study period, you will be asked to complete some questionnaires to assess your gastrointestinal symptoms along with daily stool habits and diet habits.
- The products (treatment and placebo) will be provided as a powder in capsules, they can be kept at room temperature, and also taken if travelling.
- Any adverse medical events which occur during the study (e.g. headache, gut symptoms) should be recorded in a diary along with any medication taken.
- All incidence of respiratory infections and colds should also be reported.
- Please note that you will be removed from the study if you develop acute gastrointestinal illness (e.g. food poisoning) or intolerance to the supplement or if you do not comply with the above-stated restrictions.
- You will be provided with a container for stool, saliva and urine collection which can be done at home on the morning of your visit to the University. The kits include a non-toxic stabilizing reagent and mixing apparatus and is safe for home use; personal protective equipment (e.g. gloves, eyewear, etc.) is not required. For the saliva and urine as well the kits and instructions to use will be provided by the researchers.
- All blood,saliva and urine samples will be taken during your visit to Health Sciences Research Centre, Parkstead House, Whitelands College, Holybourne Avenue, University of Roehampton, London, SW15 4JD.
- We will keep in contact with you via phone call or emails using to check on your physical condition and lifestyle during the intervention and after completion of the treatment period.
- The products used in this study are brown seaweed extracts (an extract derived from Ascophyllum nodosum) and the equivalent placebo control (maltodextrin) which will be served in capsules and these products do not pose any risk to participants. They are all food-grade and have been used in previous studies and well tolerated. However, some people who have taken other similar products have reported an increase in gas production, with slight bloating feelings, some flatulence and mild diarrhoea. Cases of this are very rare. Occasionally, people have experienced gut cramping.
- Blood, saliva, stool and urine samples will be collected by experienced staff trained for this purpose at Life Sciences Department, School of Life and Health Sciences.
- Confidentiality will be maintained by allocating you with an identification code (so data will be pseudonymous), which will be used to identify all samples and data obtained.
- Your name will not be used in any reports or publications.
- All data generated from the study will be held securely at the University of Roehampton within a password protected file, only the study investigators will have access to this a record and the names of the volunteers will not be held on the same file. Information matching volunteer names with identification codes will be kept by a departmental secretary in a locked filing cabinet, the investigators will only use identification codes.
- The only time data will be matched with volunteer names is for those volunteers that request to have their personal results. A request for individual results to be discussed will include a review of all sample results for the individual volunteer.
- All research data including a list of the names and address of the subjects in this study will be kept for a period of 10 years from completion of the project (in line with the University of Roehampton Records Retention Schedule).
- The consent forms will be kept for 6 years from completion of the project.
- All unused blood, urine and stool samples will be destroyed after the completion of the study and sample analyses. Samples will be destroyed if you withdraw from the project.
The study will be performed at Whitelands College campus of the University of Roehampton – the postal code is SW15 4JD. Upon arrival at the campus please make your way to the main reception – you will be met here. If you are driving to campus, please make sure that you know your car’s registration number so that we can record it with security.
General information:
- You will receive a £100 Amazon voucher for completing the trial. Volunteers that drop-out will have their payment pro-rated to cover the part of the study completed.
- If at any time you wish to withdraw from the study, you are completely free to do so without giving a reason. If you withdraw then the information collected may still be used for research purposes but in an anonymous, aggregate form.
- Additional analysis on blood and stool immune biomarkers will be conducted at the Universitat de Barcelona (Spain) whereas stool cytotoxic analysis will be carried out at University College Cork (Ireland). All the biological samples will be transported according to UN3373 to the collaborator’ laboratories in Spain and Ireland for further preparation and experimental analysis.
- If at any time you wish to withdraw from the study, you are completely free to do so without giving a reason. If you withdraw then the information collected may still be used for research purposes but in an anonymous, aggregate form.
- Your pseudonymised data will be shared with the Universitat de Barcelona (Spain) and the University College Cork (Ireland) who are as well involved in this study, in accordance with the Data Protection Act 2018 and with the University’s Data Protection Policy.
- The University has appropriate insurance and is well used to carrying out these types of trials. If there is a complaint then this should be addressed to Dr Adele Costabile at the University of Roehampton.
