NCT05214027

Brief Summary

Vitamin D deficiency is considered a public health priority in the UK, with approximately 30-40% of the UK population being deemed vitamin D deficient during winter months. Current government strategies to improve vitamin D status amongst the UK population involve dietary supplementation, however, it has been shown that excess adiposity reduces the impact of dietary supplementation with vitamin D. One potential explanation for this observation is that vitamin D becomes sequestered in adipose tissue. We hypothesise that exercise may facilitate the mobilisation of vitamin D from adipose tissue and thus increase circulating vitamin D (25OHD) concentrations. Little is currently known as to whether a single bout of exercise affects vitamin D status, with a handful of studies demonstrating contradictory findings. This research will examine the effect of an acute bout of exercise (treadmill-based at 60% VO2 Max for 60 minutes) on vitamin D status (serum 25(OH)D) in healthy community-dwelling adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

January 12, 2022

Last Update Submit

November 9, 2022

Conditions

Keywords

Vitamin DAcute ExerciseAdultsUnited KingdomLipid Mobilisation

Outcome Measures

Primary Outcomes (1)

  • Serum vitamin D concentration

    As assessed by serum 25(OH)D via LC-MS

    24 hours- change from baseline to 24 hours post exercise

Secondary Outcomes (3)

  • Markers of lipid mobilisation

    24 hours- change from baseline to 24 hours post exercise

  • Calcium

    24 hours- change from baseline to 24 hours post exercise

  • Other vitamin D metabolites

    24 hours- change from baseline to 24 hours post exercise

Study Arms (1)

Participants

This study follows a randomised crossover design. All participants will undergo a single 60-minute treadmill-based exercise intervention, and a resting period for equal duration in a randomised order.

Other: Treadmill-Based Exercise (60% VO2 Max for 60 minutes)Other: Rest (60 minutes)

Interventions

Each participant will undergo a single 60-minute treadmill-based exercise intervention in a randomised order. Treadmill settings are generated based on settings which correspond to participants exercising at 60% VO2 max from their maximal exercise test on visit 2. To confirm that participants are exercising at 60% during the hour session, 1 minute samples of expired air are taken at 15 minute intervals and immediately analysed to check % VO2 max. Participants heart rate and RPE measures are also taken at 15 minute intervals throughout the exercise session and cross-checked against predicted values at 60% VO2 Max.

Participants

Each participant will undergo a 60-minute rest period in a randomised order.

Participants

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy, community-dwelling adults (aged 25-65 years old)

You may not qualify if:

  • years old
  • Ability to travel to and from University of Bath campus
  • Current or recent use (within the last three months) of weight loss drugs, medication that would interfere with study outcomes, sunbeds, or dietary vitamin D supplementation
  • Change in weight of more than 5% in the last six months, or a significant change in lifestyle in the last two months
  • Positive responses to the Physical Activity Readiness Questionnaire (PAR-Q)
  • Presence of coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, peripheral arterial disease, severe hypertension (blood pressure \>180/110 mmHg)
  • BMI \<18kg/m2 or BMI \>40kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sophie Ella Davies

Bath, Somerset, BA1 6AW, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human Plasma and Serum

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 28, 2022

Study Start

April 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations