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

NCT06147323 | Recruiting DMC

• 1 other identifier: LSC 23/388
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (8)

• Changes in blood glucose levels

  To investigate the effects of dietary intervention on blood glucose levels of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in insulin sensitivity

  To investigate the effects of dietary intervention on insulin levels of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in gut microbiome

  To investigate the effects of dietary intervention on gut microbiome of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in pro and anti-inflammatory biomarkers

  To investigate the effects of dietary intervention on immunity of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in metabolic profile

  To investigate the effects of dietary intervention on metabolic signature of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in dietary habits

  To investigate the effects of dietary intervention on dietary habits of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in blood pressure

  To investigate the effects of dietary intervention on blood pressure of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in quality of life

  To investigate the effects of dietary intervention on quality of life of pre-diabetics

  Changes from baseline to 6 and 12 weeks of the intervention

Study Arms (3)

Normal Healthy Diet group

ACTIVE COMPARATOR

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/).

Other: Normal Healthy Diet

Placebo Group

PLACEBO COMPARATOR

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.

Other: Placebo Diet Group

Seaweed Group

ACTIVE COMPARATOR

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.

Dietary Supplement: Seaweed Group

Interventions

Normal Healthy Diet OTHER

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/).

Also known as: Eatwell diet Control

Normal Healthy Diet group

Seaweed Group DIETARY_SUPPLEMENT

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.

Seaweed Group

Placebo Diet Group OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead
• Universitat Autonoma de Barcelona: collaborator
• University College Cork: collaborator

Study Sites (1)

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

London, UK, SW15 4JD, United Kingdom

RECRUITING

Related Links

• Studies website

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• ADELE COSTABILE, Dr

  University of Roehampton

  STUDY DIRECTOR

Central Study Contacts

ADELE COSTABILE, Dr

CONTACT

02083923571; adele.costabile@roehampton.ac.uk

Beyda Beteri, Ms

CONTACT

beyda.beteri@roehampton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Nutrition and Health

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 27, 2023
• Study Start: November 13, 2023
• Primary Completion: July 17, 2024
• Study Completion (Estimated): August 12, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)