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| Name | Class |
|---|---|
| Universitat Autonoma de Barcelona | OTHER |
| University College Cork | OTHER |
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The research area that focuses on the links between nutrition and health, nutrition and the immune system as well as nutrition-related public health interventions, which often falls into the gap between the agricultural and health domains. The rationale of this project is to study the influence of beneficial diets on the immune system of pre-diabetic patients and its potential to counteract infections. A clinical, an in vitro (cell systems) and an in vivo (animal model) approach will be used to study the influence of a seaweed bioactive supplement and a diet rich in components from a Mediterranean diet on a Salmonella typhimurium infection in prediabetic subjects. At the end of this project, we will provide evidence on the potential of these nutritional interventions to counteract infection, which are of high relevance to the society to reduce the burden of type 2 diabetes (T2DM) and obesity. This research is part of an ongoing research project funded by the Research State Agency (Spain), Health Research Board (HRB, Ireland) and the Medical Research Council (MRC-UKRI, UK) via the NUTRIMMUNE' Grant of the Joint Programming Initiative a Healthy Diet for a Healthy Life (JPI-HDHL).
The aim of this study is to evaluate the effects of different diets on gut health, immune and metabolic markers, in individuals aged between 18-65 years who are defined as pre-diabetics and adults in general good health.
About 45 volunteers will take part in this study and they will then be randomly assigned a volunteer number and placed in one of three study group for a total of 12 weeks:
At baseline (week 0), week 6, week 12 and week 16, volunteers will be required to visit the University of Roehampton to provide fasted blood, saliva, stool and first pass urine samples and have blood pressure, body fat and weight measured.
During the study period, they will be asked to complete some questionnaire to assess your gastrointestinal symptoms along with daily stool habits and diet habits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Healthy Diet group | Active Comparator | Participants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/). |
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| Placebo Group | Placebo Comparator | Participants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow. |
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| Seaweed Group | Active Comparator | Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Healthy Diet | Other | Participants aged 18-65 years in general good health will be following the Eatwell booklet advice*and NICE/NHS guidelines (https://www.nice.org.uk/). |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood glucose levels | To investigate the effects of dietary intervention on blood glucose levels of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in insulin sensitivity | To investigate the effects of dietary intervention on insulin levels of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in gut microbiome | To investigate the effects of dietary intervention on gut microbiome of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in pro and anti-inflammatory biomarkers | To investigate the effects of dietary intervention on immunity of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in metabolic profile | To investigate the effects of dietary intervention on metabolic signature of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in dietary habits | To investigate the effects of dietary intervention on dietary habits of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in blood pressure | To investigate the effects of dietary intervention on blood pressure of pre-diabetics |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| ADELE COSTABILE, Dr | University of Roehampton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Research Centre, Life Sciences Department, University of Roehampton | London | UK | SW15 4JD | United Kingdom |
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| Label | URL |
|---|---|
| Studies website | View source |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Seaweed Group | Dietary Supplement | Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsules/day (information detailed in the safety product sheet, total dose of 700 mg before each of the two main meals. All participants will be advised on product storage and use conditions prior to use to ensure product consistency throughout the period of the study. |
|
| Placebo Diet Group | Other | Participants aged 18-65 prediabetics will take 2 capsules/day (750mg Maltodextrin placebo comparator) before each of the two main meals without any advice on the diet to follow. |
|
| Changes from baseline to 6 and 12 weeks of the intervention |
| Changes in quality of life | To investigate the effects of dietary intervention on quality of life of pre-diabetics | Changes from baseline to 6 and 12 weeks of the intervention |