Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients (PreVegDiet)
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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. On giving consent and passing initial screening, your blood pressure, height, weight and body fat will be measured, and you will be asked to give a blood sample for screening (10 ml; 1 dessert spoon).
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 12 weeks.
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Normal Healthy Diet group (N=15): 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 (N=15): 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.: 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.
Once the study begins, you will allocate one of the study groups for 12 weeks. You will remain in the study for another 4 weeks, but you will not be asked to consume any treatment (this is called a washout period).
At baseline (week 0), week 6, week 12 and week 16, you 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, you will be asked to complete some questionnaire to assess your gastrointestinal symptoms along with daily stool habits and diet habits.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Normal Healthy Diet group 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/). |
Other: Normal Healthy Diet
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/).
Other Names:
|
| Placebo Comparator: Placebo Group 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. |
Other: Placebo Diet Group
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.
|
| Active Comparator: Seaweed Group 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. |
Dietary Supplement: Seaweed Group
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.
|
Outcome Measures
Primary Outcome Measures
- Changes in blood glucose levels [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on blood glucose levels of pre-diabetics
- Changes in insulin sensitivity [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on insulin levels of pre-diabetics
- Changes in gut microbiome [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on gut microbiome of pre-diabetics
- Changes in pro and anti-inflammatory biomarkers [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on immunity of pre-diabetics
- Changes in metabolic profile [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on metabolic signature of pre-diabetics
- Changes in dietary habits [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on dietary habits of pre-diabetics
- Changes in blood pressure [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on blood pressure of pre-diabetics
- Changes in quality of life [Changes from baseline to 6 and 12 weeks of the intervention]
To investigate the effects of dietary intervention on quality of life of pre-diabetics
Eligibility Criteria
Criteria
Inclusion criteria
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Adults aged between 18 and 60 years, with
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Fasting blood glucose level of 5.6-6.9mmol/L or impaired HbA1c (HbA1c level of 5.7%-6.4%)
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Fasting blood glucose level below 5.6mmol/L or HbA1c level below 5.7%.
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For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
Exclusion criteria
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People with a current diagnosis or clinical history of T2DM
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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.
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People who are already participating in a weight loss programme
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People receiving drug treatment for pre-diabetes (eg, metformin)
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People with a history of long-term use of medicines known to influence glucose metabolism (eg, corticosteroids)
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People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
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People who take antibiotics or bacterial agents (Probiotics) within 1 month
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Pregnant women, women ready for pregnancy, and nursing mothers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Health Sciences Research Centre, Life Sciences Department, University of Roehampton | London | UK | United Kingdom | SW15 4JD |
Sponsors and Collaborators
- University of Roehampton
- Universitat Autonoma de Barcelona
- University College Cork
Investigators
- Study Director: ADELE COSTABILE, Dr, University of Roehampton
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- LSC 23/388