- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07300332
Exercise Training and Vitamin D Metabolism (Hybri-D)
May 22, 2026 updated by: Dimitrios Draganidis, University of Thessaly
The Impact of Hybrid-type High-intensity Interval Training on Vitamin D Metabolism in Adults With Overweight/Obesity
The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal body mass index (BMI).
The "entrapment" of Vitamin D in adipose tissue due to impaired lipolytic stimulation and/or adipose tissue dysfunction has been proposed as the driving mechanism.
Exercise training has been proposed as a promising strategy to increase mobilization of Vitamin D from adipose tissue, given its well described role in stimulating lipolysis.
Indeed, a recent study revealed that participation in moderate-intensity cardiovascular type exercise over winter can mitigate the decline in 25-hydroxyvitamin D [25(OH)D] in adults with overweight/obesity, independent of weight loss.
The aim of this study is to investigate the impact of hybrid-type high-intensity interval training over winter on vitamin D metabolism, in adults with overweight/obesity.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Thirty adults with overweight/obesity (both males and females) who will meet the inclusion criteria will be randomly assigned to either an Exercise group (n=15) or a Control group (n=15).
The Exercise group will participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period, while receiving a balanced diet.
The Control group will receive a balanced diet but will not participate in exercise training.
Both groups will provide a resting blood sample and undergo assessment of their body composition (via bioelectrical impedance analysis), daily dietary intake (via dietary recalls) and physical activity level (via accelerometry) at baseline (prior to intervention), 6 weeks and 12 weeks.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dimitrios Draganidis, PhD
- Phone Number: +302431047078
- Email: ddraganidis@uth.gr
Study Contact Backup
- Name: Ioannis G Fatouros, PhD
- Phone Number: 2431047047
- Email: ifatouros@uth.gr
Study Locations
-
-
Karyes
-
Trikala, Karyes, Greece, 42100
- Recruiting
- Department of Physical Education and Sport Science, University of Thessaly
-
Contact:
- Ioannis G Fatouros, PhD
- Phone Number: 2431047047
- Email: ifatouros@uth.gr
-
Contact:
- Athanasios Z Jamurtas, PhD
- Phone Number: 2431047054
- Email: ajamurt@uth.gr
-
Sub-Investigator:
- Eytychia Giouvri, BSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI = 25-35 kg/m2
- Absence of musculoskeletal injuries
- Absence of chronic health-related complications
- Non-smokers
Exclusion Criteria:
- Consumption of Vitamin D supplements
- Consumption of anti-inflammatory drugs, statins and/or steroids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Exercise group will participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period, while receiving a balanced diet
|
Receive a balanced diet and participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period
|
|
Active Comparator: Control group
Control group will receive a balanced diet but will not participate in exercise training
|
Receive a balanced diet but abstain from any type of exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in calcium concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
Calcium concentration will be determined in serum
|
At baseline, 6 weeks and 12 weeks
|
|
Change in albumin concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
Albumin concentration will be determined in serum
|
At baseline, 6 weeks and 12 weeks
|
|
Change in 25-hydroxyvitamin D concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
25-OH-VD will be quantitatively determined in serum
|
At baseline, 6 weeks and 12 weeks
|
|
Change in plasma Vitamin D binding protein concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
Vitamin D binding protein concentration will be determined in plasma
|
At baseline, 6 weeks and 12 weeks
|
|
Change in aspartate aminotransferase (SGOT) concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
SGOT concentration will be determined in serum on a Clinical Chemistry analyzer
|
At baseline, 6 weeks and 12 weeks
|
|
Change in alanine aminotransferase (SGPT) concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
SGPT concentration will be determined in serum on a Clinical Chemistry analyzer
|
At baseline, 6 weeks and 12 weeks
|
|
Change in gamma-glutamyl transferase (γ-GT) concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
γ-GT concentration will be determined in serum on a Clinical Chemistry analyzer
|
At baseline, 6 weeks and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in dietary intake
Time Frame: At baseline, 6 weeks and 12 weeks
|
Dietary intake habits will be assessed through dietary recalls
|
At baseline, 6 weeks and 12 weeks
|
|
Change in physical activity level
Time Frame: At baseline, 6 weeks and 12 weeks
|
Physical activity will be assessed via accelerometry
|
At baseline, 6 weeks and 12 weeks
|
|
Change in body composition
Time Frame: At baseline, 6 weeks and 12 weeks
|
Body composistion will be assessed via bioelectrical impedance analysis (BIA)
|
At baseline, 6 weeks and 12 weeks
|
|
Change in reduced glutathione concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
Reduced glutathione concentration will be determined in blood erythrocytes
|
At baseline, 6 weeks and 12 weeks
|
|
Change in oxidized glutathione concentration
Time Frame: At baseline, 6 weeks and 12 weeks
|
Oxidized glutathione concentration will be determined in blood erythrocytes
|
At baseline, 6 weeks and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dimitrios Draganidis, PhD, University of Thessaly
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2025
Primary Completion (Actual)
January 31, 2026
Study Completion (Estimated)
July 20, 2026
Study Registration Dates
First Submitted
December 9, 2025
First Submitted That Met QC Criteria
December 9, 2025
First Posted (Actual)
December 23, 2025
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 22, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTH_2612_8.10.2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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