Effects of a High Fiber and Plant Protein Diet on Gut Health in Prediabetic Patients
University of Roehampton
This study is testing whether a Mediterranean diet with seaweed supplements can improve gut health and immune function in people who are prediabetic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Roehampton Academic / other |
| Locations | 1 site (London, UK) |
| Trial ID | NCT06147323 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different diets, particularly a Mediterranean diet enriched with seaweed bioactive supplements, affect gut health and immune markers in prediabetic individuals. A total of 45 volunteers aged 18-65 will be randomly assigned to one of three groups: a normal healthy diet, a placebo group, or a seaweed supplement group, over a 12-week period. Participants will undergo various assessments, including blood, saliva, stool, and urine sample collection, along with measurements of blood pressure and body composition at multiple time points. The goal is to determine the potential of these dietary interventions to improve immune responses and reduce the risk of type 2 diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who are prediabetic, with specific fasting blood glucose or HbA1c levels.
Not a fit: Patients with a current diagnosis of type 2 diabetes or significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary strategies that enhance gut health and immunity, potentially reducing the risk of developing type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with dietary interventions in prediabetic populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, UK
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton — London, UK, United Kingdom (Recruiting)
Study contacts
- Study coordinator: ADELE COSTABILE, Dr
- Email: adele.costabile@roehampton.ac.uk
- Phone: 02083923571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.