Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147323
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-11-14
Brief Title:
Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients
Sponsor:
University of Roehampton
Organization:
University of Roehampton
Study Overview
Official Title:
University of Roehampton
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreVegDiet
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
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 and they will then be randomly assigned a volunteer number and placed in one of three study group for a total of 12 weeks
1 Normal Healthy Diet group N15 Participants aged 18-65 years in general good health will be following the Eatwell booklet adviceand NICENHS guidelines httpswwwniceorguk
2 Placebo group N15 Participants aged 18-65 prediabetics will take 2 capsulesday 750mg Maltodextrin placebo comparator before each of the two main meals without any advice on the diet to follow
3 Seaweed Group Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsulesday 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
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
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
1 Normal Healthy Diet group N15 Participants aged 18-65 years in general good health will be following the Eatwell booklet adviceand NICENHS guidelines httpswwwniceorguk
2 Placebo group N15 Participants aged 18-65 prediabetics will take 2 capsulesday 750mg Maltodextrin placebo comparator before each of the two main meals without any advice on the diet to follow
3 Seaweed Group Participants aged 18-65 prediabetics will take 2 seaweeds brown extract capsulesday 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None