Vitamin D deficiency Nutritional, Metabolic, Endocrine
Conditions
Interventions
This study uses a classic randomised control trial study design, combined with cross-sectional group comparison.
For the randomised control trial (RCT) arm of the trial, 50 overweight adults who are
n=25), or to undertake an exercise intervention for 10 weeks (exercise group
n=25). The exercise group will be required to stay weight stable during the intervention period, thus allowing the effect of exercise alone to be investigated. Vitamin D status and metabolism will be
Sponsors
University of Bath
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1: 10-week RCT in overweight men and women 1. Aged 25-65 years 2. Fat Mass Index (FMI) determined using DEXA of 7.5-15 kg/m2 (?) and 11-21 kg/m2 (?). 3. Self-reported participation in no vigorous intensity physical activity and less than 150 minutes of moderate intensity activity per week AND an objectively assessed Physical Activity Level (PAL) less than 2.00 (total energy expenditure/resting energy expenditure) 4. Available during the winter months (October-March) 5. Non-smoker Group 2: Lean comparator group 1. Aged 25-65 years 2. Fat Mass Index (FMI) determined using DEXA of 2-6 kg/m2 (?) and 4-9 kg/m2 (?). 3. Self-reported participation in either 150 minutes of moderate intensity or 75 minutes of vigorous intensity physical activity per week AND an objectively assessed Physical Activity Level (PAL) greater than 1.75 4. Available during the winter months (October-March) 5. Non-smoker
Exclusion criteria
Exclusion criteria: Group 1: 10-week RCT in overweight men and women 1. Current or recent use of weight loss drugs 2. Any reported recent (i.e. last 6 months) shift (> 5%) in body mass or large change in habitual lifestyle 3. Individuals with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure and peripheral arterial disease 4. Individuals with ‘severe hypertension’ defined as a blood pressure greater than 180/110 mmHg (British Hypertension Society and NICE guidelines – CG127) 5. Individuals unable to change their physical activity (e.g. through disability) 6. Positive responses to the Physical Activity Readiness Questionnaire (PAR-Q) 7. Recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention. (Participants will be asked not to donate blood whilst participating in the study) 8. Taking medication that might interfere with the study outcomes 9. Regular consumption of dietary supplements containing vitamin D 10. Regular use of sunbeds 11. Abnormal resting ECG (for arteriovenous difference participants, only) 12. Sensitivity or allergy to lidocaine or any local anaesthetic medicines. 13. Pregnancy Group 2: Lean comparator group 1. Current or recent use of weight loss drugs 2. Any reported recent (i.e. last 6 months) shift (> 5%) in body mass or large change in habitual lifestyle 3. Individuals with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure and peripheral arterial disease 4. Individuals with ‘severe hypertension’ defined as a blood pressure greater than 180/110 mmHg (British Hypertension Society and NICE guidelines – CG127) 5. Positive responses to the Physical Activity Readiness Questionnaire (PAR-Q) 6. Recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention. (Participants will be asked not to donate blood whilst participating in the study) 7. Taking medication that might interfere with the study outcomes 8. Regular consumption of dietary supplements containing vitamin D 9. Regular use of sunbeds 10. Abnormal resting ECG (for arteriovenous difference participants, only) 11. Sensitivity or allergy to lidocaine or any local anaesthetic medicines. 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitamin D ‘status’ is measured using serum 25OHD, pre- and post- 10 weeks of exercise | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vitamin D metabolite and vitamin D binding protein concentrations are measured in serum by mass spectrometry, pre- and post- 10 weeks of exercise 2. Urinary excretion of vitamin D metabolites is measured pre- and post- 10 weeks of exercise 3. Whole-body vitamin D turnover and metabolism is measured using stable isotopes for 4 weeks before, and during the last 4 weeks, of 10 weeks of exercise 4. Vitamin D bioavailability is measured via the function of monocytes cultured in participant serum pre- and post- 10 weeks of exercise 5. Adipose and skeletal muscle vitamin D content is measured by mass spectrometry, pre- and post- 10 weeks of exercise 6. Adipose vitamin D mobilisation (ex vivo) is measured by adipose tissue explant culturing under conditions stimulating lipolysis, pre- and post- 10 weeks of exercise 7. Adipose tissue transcriptome is measured using RNAseq pre- and post- 10 weeks of exercise 8. Protein expression (based on targets from RNAseq) measured by Western blotting, pre- and post- 10 weeks of exercise 9. Adipose and muscle arteriovenous differences for vitamin D metabolites, acylcarnitine, and calcitroic acid, in response to stimulation is measured by mass spectrometry pre- and post- 10 weeks of exercise (in a subset of participants only) 10. Fasted and fed serum hormones (e.g., insulin, appetite regulatory hormones) in a mixed meal tolerance test are measured by ELISA, multiplex assay, and mass spectrometry, pre- and post- 10 weeks of exercise 11. Systemic cytokines in serum and plasma are measured by ELISA and multiplex assay, pre- and post- 10 weeks of exercise 12. Blood and adipose tissue (stromal vascular fraction) immune cell phenotypes are measured by flow cytometry pre- and post- 10 weeks of exercise 13. Incidence of upper-respiratory tract infections measured by weekly questionnaires for the 4 weeks before, and during 10 weeks of structured exercise (added 31/03/2022): along with salivary IgA and LL-37 levels pre-, mid-way-through-, and po | — |
Countries
England, United Kingdom
Outcome results
None listed