University of Roehampton

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Adults aged between 18 and 60 years, with

• Fasting blood glucose level of 5.6-6.9mmol/L or impaired HbA1c (HbA1c level of 5.7%-6.4%)

• Fasting blood glucose level below 5.6mmol/L or HbA1c level below 5.7%.

• For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.

Locations
Other Locations
United Kingdom
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
RECRUITING
London
Contact Information
Primary
ADELE COSTABILE, Dr
adele.costabile@roehampton.ac.uk
02083923571
Backup
Beyda Beteri, Ms
beyda.beteri@roehampton.ac.uk
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2026-08-12
Participants
Target number of participants: 45
Treatments
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/).
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: University College Cork, Universitat Autonoma de Barcelona
Leads: University of Roehampton

This content was sourced from clinicaltrials.gov