NCT05863078

Brief 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?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

February 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

February 8, 2023

Last Update Submit

November 20, 2024

Conditions

Keywords

Menus of ChangeArterial stiffness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Full blood count

    up to 2 weeks after completing a 3-day food diary

  • Lipid profile

    up to 2 weeks after completing a 3-day food diary

  • Glucose levels

    up to 2 weeks after completing a 3-day food diary

  • liver profile

    up to 2 weeks after completing a 3-day food diary

  • Kidney profile

    up to 2 weeks after completing a 3-day food diary

  • +2 more secondary outcomes

Other Outcomes (3)

  • Depression and anxiety survey

    up to 2 weeks before the study visit

  • Academic attainment

    By the end of academic year

  • Urine dietary biomarkers level

    24-hours before the study visit

Study Arms (2)

Group following the Menus of Change diet

Group not following the menus of Change diet

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants eating in the university halls following the Menus of Change diet will be selected and compared to participants living in the university halls but not following the Menus of Change and therefore eating outside the university dining halls

You may qualify if:

  • Adults
  • Home students living in university halls
  • Undergraduates
  • Can understand participant information sheet and willing to comply with the study design

You may not qualify if:

  • International students
  • postgraduates
  • living outside the university halls
  • participating in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples will be taken from participants.

Central Study Contacts

Charlotte Mills, PhD

CONTACT

Youmna Hussein, PharmD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

May 17, 2023

Study Start

January 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 22, 2024

Record last verified: 2024-11