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

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).

Conditions

• Pre-diabetes

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.

Sponsors & Collaborators

• Universitat Autonoma de Barcelona

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University of Roehampton

  lead OTHER

Principal Investigators

• ADELE COSTABILE, Dr · University of Roehampton

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-13

Primary Completion

2024-07-17

Completion

2025-12-12

Countries

• United Kingdom

Study Locations