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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05863078
Other study ID # TBC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 2026

Study information

Verified date May 2023
Source University of Reading
Contact Charlotte Mills, PhD
Phone 01183787108
Email c.e.mills@reading.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this cross-sectional study is to investigate the health benefits of the Menus of Change in undergraduate university students, by comparing 2 groups: Students eating in the Menus of change catered halls, versus students eating outside the Menus of change meal plan. The main question it aims to answer is: What are the effects of the menus of change on other vascular outcomes, namely blood pressure? What are the effects of the menus of change on other health markers?


Description:

The Menus of Change (MoC) is an example of behaviour change that was created by The Culinary Institute of America (CIA) and Harvard TH Chan School of Public Health. This initiative is based on a set of around 24 core principles, mainly promoting and serving 'healthy, sustainable, and delicious' food in restaurants and foodservice operations. The University of Reading has successfully implemented the MoC across the campus and in students' accommodations. However, MoC is not implemented across all campus halls. To date, most of the studies performed in relation to the MoC had explored techniques to encourage students towards healthier, more sustainable diets. Very little research focuses on the associated health outcomes and hence the impact on health of the eating pattern laid out in the MoC principles. Therefore, this project aims to investigate the health impact of the menu of change on university students, by comparing 2 groups: students eating in MoC catered halls, following the meal plan provided by the university food services, versus students who do not follow the menus of change meal plan. The primary aim will be to investigate the effect of the MoC on vascular outcomes, namely arterial stiffness, a particularly important tool in younger adults with low-moderate cardiovascular disease risk. Secondary aims will be to investigate other vascular outcomes, namely blood pressure changes, as well as looking at other health markers, such as full blood count, lipid profile, sugar levels, liver and kidney function, and CVD related inflammatory markers. In addition, the study aims to look at the impact of the MoC on stress and anxiety levels and the differences in students' attainment between groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Adults - Home students living in university halls - Undergraduates - Can understand participant information sheet and willing to comply with the study design Exclusion Criteria: - International students - postgraduates - living outside the university halls - participating in other studies

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Reading

Outcome

Type Measure Description Time frame Safety issue
Other Depression and anxiety survey Beck's depression survey, STAI 1 and PANAS up to 2 weeks before the study visit
Other Academic attainment To assess the relationship between healthy diet and academic results By the end of academic year
Other Urine dietary biomarkers level by 24-hours urine sample 24-hours before the study visit
Primary Arterial stiffness Arterial stiffness will be measured using Mobil-O-Graph to assess the cardiovascular risk in participants up to 2 weeks after completing a 3-day food diary
Secondary Full blood count Full blood count levels will be compared between both groups up to 2 weeks after completing a 3-day food diary
Secondary Lipid profile Lipid profile levels will be compared between both groups up to 2 weeks after completing a 3-day food diary
Secondary Glucose levels by comparing levels between both groups up to 2 weeks after completing a 3-day food diary
Secondary liver profile comparing liver profile levels between both groups up to 2 weeks after completing a 3-day food diary
Secondary Kidney profile kidney profile levels to be compared between both groups up to 2 weeks after completing a 3-day food diary
Secondary SCFA levels short chain fatty acids levels to be compared between both groups up to 2 weeks after completing a 3-day food diary
Secondary Cardiovascular disease related inflammatory biomarkers Levels to be compared between both groups up to 2 weeks after completing a 3-day food diary
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