The Effects of an 8-week Vegan Diet on TMAO Levels and Post-challenge Glucose Levels in Individuals With Dysglycaemia — PYH  

Diabetes Mellitus, Type 2 Clinical Trial

Official title: The Effects of an 8-week Vegan Diet on Trimethylamine-N-Oxide (TMAO) Levels and Post-challenge Glucose Levels in Individuals With Dysglycaemia (The Plant Your Health Study)

Status Completed

Clinical Trial Summary

The amount of people with diabetes mellitus has now reached over 4 million in the United Kingdom. Type 2 diabetes accounts for the majority of all cases of diabetes and increases the risk of many other diseases such as heart problems. Plant based diets are thought to be an effective way to improve markers of health related to type 2 diabetes and heart disease. One way that a plant based diet improves health could be through reducing waste products that are generated in the gut by the bacteria that break down food as part of the digestion process. For example, the digestion of some meats, fish and eggs results in the creation of a substance called Trimethylamine-N-Oxide (TMAO) which has been linked to worse health outcomes in several studies. However, the full impact on TMAO and blood glucose levels of swapping regular meat consumption for a plant based vegan diet is not fully understood and requires further research. Therefore, the aim of this study will be to develop and undertake a clinical trial to investigate the effects of an 8-week vegan diet on TMAO levels and post challenge glucose levels in individuals with dysglycaemia (drug naïve).

The study will be interventional single group prospective trial of adults aged 18-75 years of age from a multi-ethnic population with dysglycaemia (drug naïve). A sample of 29 people will be sought. The dietary intervention (vegan diet) will last 8 weeks. Then, the participants will go back to their normal diet and come for their final visit after a four week follow-up period (week 12). To assess the effectiveness of the intervention, primary and secondary outcome data collected at baseline will be compared with data collected at 1 week, 8 weeks and 12 weeks.

Clinical Trial Description

Study Design

Interventional single group prospective trial in a patient population with identified dysglycaemia within the past 36 months defined as 2h post-challenge glucose ≥7.8 mmol/L after a standard oral glucose tolerance test or HbA1c ≥5.7% (39-46 mmol/mol). This phase clinical trial will evaluate the efficacy and underlining mechanisms of a vegan diet in promoting cardiometabolic health in those with dysglycaemia. Specifically, this trial will aim to investigate the effect of an 8-week vegan diet with follow-up at 1, 8 and 12 weeks.

Study Setting

The study will be co-ordinated within the Leicester Biomedical Research Centre (Leicester Diabetes Centre) at the Leicester General Hospital. Clinical measurement sessions will be carried out by the appointed research team. Participants will be asked to visit the study centre on five occasions.

Intervention Description and Definition

The participants will be asked to follow a diet that excludes foods hypothesised to support the syntheses of TMAO, particularly meat (any), eggs and fish (any). A number of studies suggest that dairy products may also have an effect in modulating TMAO production whereas other studies do not. Therefore, in order to avoid any potential contaminating or confounding effect, dairy products will also be avoided.

The diet employed in this study is broadly aligned to a vegan diet. The term vegan will be used to aid behaviour change and food choice. For example, an increasing array of products are now pack marked as vegan. The participants will be asked to keep their diet similar to their original and the Registered Dietitian involved in this study will plan their weekly menus accordingly. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Heart Diseases

• NCT number: NCT03315988
• Study type: Interventional
• Source: University of Leicester
• Status: Completed
• Phase: N/A
• Start date: October 4, 2017
• Completion date: January 7, 2019