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RECRUITING
NCT06147323
NA

Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients

Sponsor: University of Roehampton

View on ClinicalTrials.gov

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).

Official title: University of Roehampton

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2023-11-13

Completion Date

2026-08-12

Last Updated

2024-07-22

Healthy Volunteers

Yes

Conditions

Interventions

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/).

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.

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.

Locations (1)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, United Kingdom