Status:
RECRUITING
Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients
Lead Sponsor:
University of Roehampton
Collaborating Sponsors:
Universitat Autonoma de Barcelona
University College Cork
Conditions:
Pre-diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 betwe...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria
- People with a current diagnosis or clinical history of T2DM
- 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.
- People who are already participating in a weight loss programme
- People receiving drug treatment for pre-diabetes (eg, metformin)
- People with a history of long-term use of medicines known to influence glucose metabolism (eg, corticosteroids)
- People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
- People who take antibiotics or bacterial agents (Probiotics) within 1 month
- Pregnant women, women ready for pregnancy, and nursing mothers
Exclusion
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06147323
Start Date
November 13 2023
End Date
August 12 2026
Last Update
July 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom, SW15 4JD