NCT07300332

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Nov 2025Jul 2026

Study Start

First participant enrolled

November 10, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Expected
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

December 9, 2025

Last Update Submit

May 22, 2026

Conditions

Keywords

overweightobesityvitamin D25-hydroxyvitamin Dhigh-intensity interval training

Outcome Measures

Primary Outcomes (7)

  • Change in 25-hydroxyvitamin D concentration

    25-OH-VD will be quantitatively determined in serum

    At baseline, 6 weeks and 12 weeks

  • Change in plasma Vitamin D binding protein concentration

    Vitamin D binding protein concentration will be determined in plasma

    At baseline, 6 weeks and 12 weeks

  • Change in calcium concentration

    Calcium concentration will be determined in serum

    At baseline, 6 weeks and 12 weeks

  • Change in albumin concentration

    Albumin concentration will be determined in serum

    At baseline, 6 weeks and 12 weeks

  • Change in aspartate aminotransferase (SGOT) concentration

    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

    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

    γ-GT concentration will be determined in serum on a Clinical Chemistry analyzer

    At baseline, 6 weeks and 12 weeks

Secondary Outcomes (5)

  • Change in reduced glutathione concentration

    At baseline, 6 weeks and 12 weeks

  • Change in oxidized glutathione concentration

    At baseline, 6 weeks and 12 weeks

  • Change in dietary intake

    At baseline, 6 weeks and 12 weeks

  • Change in physical activity level

    At baseline, 6 weeks and 12 weeks

  • Change in body composition

    At baseline, 6 weeks and 12 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Other: Exercise training

Control group

ACTIVE COMPARATOR

Control group will receive a balanced diet but will not participate in exercise training

Other: Control

Interventions

Receive a balanced diet and participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period

Exercise group
ControlOTHER

Receive a balanced diet but abstain from any type of exercise training

Control group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI = 25-35 kg/m2
  • Absence of musculoskeletal injuries
  • Absence of chronic health-related complications
  • Non-smokers

You may not qualify if:

  • Consumption of Vitamin D supplements
  • Consumption of anti-inflammatory drugs, statins and/or steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Science, University of Thessaly

Trikala, Karyes, 42100, Greece

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dimitrios Draganidis, PhD

    University of Thessaly

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Draganidis, PhD

CONTACT

Ioannis G Fatouros, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 23, 2025

Study Start

November 10, 2025

Primary Completion

January 31, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations