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Vitamin D as a Factor Modifying Adaptation to Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417700
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Olek, Gdansk University of Physical Education and Sport

Brief Summary:

Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a countermeasure against many diseases often accompanied by the acute or chronic low grade inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect of exercise. Based on current knowledge of the topic, own experience and preliminary work, it is expected the proposed research to provide information on the mechanism either determining or limiting pro-healthy effects of exercise in different age groups of people. Three different training programmes will be investigated. Specific goals of the project include the following:

  1. Establish, whether regular Nordic Walking training and HIIT can reduce the low-grade systemic inflammation and which type of training is the most effective at doing so.
  2. Establish, whether regular training can prevent muscle sarcopenia and assess if those changes are related to the concentration of the autophagy-inducing stress protein, HMGB1.
  3. Establish, whether regular Nordic Walking training alters iron metabolism and evaluate its correlation with the inflammatory markers and bone-morphogenesis.
  4. Establish, whether muscle-released irisin signals growth in the BDNF concentration in response to exercise and if these changes improve cognitive function.
  5. Establish, whether Nordic Walking or HIIT training effectively improve the blood lipid profile and aerobic capacity, and if these effects correlate with the blood 25-OHD concentration.
  6. Establish, whether concentration of vitamin D alters adaptation to training and modifies immunological response to regular training process.

Condition or disease Intervention/treatment Phase
Vitamin D3 Deficiency Dietary Supplement: NW training Dietary Supplement: Placebo Dietary Supplement: HICT Not Applicable

Detailed Description:

The mechanism behind the anti-inflammatory effect of exercise is not fully understood. In some cases physical activity has proven almost/completely ineffective in reducing systemic inflammation. Thus, evaluating factors, which modify this response, is of particular significance. One of them may be related to iron metabolism. It is has been suggested that regular training reduces body iron stores, which can contribute to the anti-inflammatory response. Consequently, one of the anti-inflammatory effects of exercise can be related to changes in iron metabolism. Nevertheless, our preliminary data demonstrated that eight months of Nordic Walking training did not reduce body iron stores in approx. 25% of subjects, even if some of them were characterized by high blood ferritin (good indicator of body iron stores). This may be related to the effect of exercise on the concentration of hepcidin (main regulator of iron absorption, which acts as a negative regulator of iron efflux). It is well documented that a single bout of exercise induces an increase in blood hepcidin; however, data on the effect of regular training on the hepcidin concentration are limited.

Vitamin D is another factor, which could influence the anti-inflammatory effect of exercise. It has been suggested that individuals involved in physical activity have higher concentrations of 25OHD (indicator of vitamin D status). Vitamin D inhibits the expression of pro-inflammatory cytokines, which is considered the main mechanism of its anti-inflammatory action. It is worth noting that population in Poland is characterized by low status of vitamin D. Thus, it is possible that the anti-inflammatory effect of exercise will be modified by the vitamin status. Moreover, vitamin D has been shown to protect against muscle atrophy both in elderly and younger people. Its concentration has been correlated with muscle strength.

Inflammation has been observed to be associated with an increase of the autophagy-inducing stress protein, HMGB1, which mediates muscle atrophy. Measurement of plasma amino acid profile will be helpful to assess the impact of exercise on muscle proteolysis. Moreover, the link between exercise, vitamin D status and HMGB1 has not yet been established. In addition, a range of interactions induced by exercise involves the release of the newly discovered protein, irisin, form the muscle and its improving effect on the cognitive function through the synthesis of brain-derived neurotrophic factor (BDNF). Data on the effect of regular training on irisin concentration in elderly people is lacking.

Overall, our research interest focuses on the role of the factors mediating the anti-inflammatory effect of exercise and the way they stimulate or inhibit adaptive changes. The proposed project draws on our long experience in investigating the effects of exercise on iron metabolism as well as other physical methods supporting the anti-inflammatory action of physical activity. Latest published papers indicate that the concentration of vitamin D, also in training adaptation, can modulate immunological response to exercise. Therefore, verifying our hypothesis would also allow us to determine if the concentration of vitamin D can limit adaptation to physical activity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Model I

Women and men over 65 years old will participate in the training programme. All subjects will undergo a medical check-up before being subject to exercise. All procedures will be performed with the approval from the Bioethical Committee of the Regional Medical Society in Gdansk. One week prior to the beginning of the experiment, a battery of physiological and psychological tests will be performed. The same procedure will be repeated after the training period.

In addtition to training, supplementation of vitamin D (800IU and 4000IU) will be administered.

Model II

Young women will participate in the training programme. They will perform a high-intensity circuit training according to the ACSM. They will perform a single session of HICT and 12 units of HICT regularly. One week prior to the beginning of the experiment, a battery of physiological and psychological test will be performed. The same procedure will be repeated after the training period.

Masking: Single (Investigator)
Masking Description: Participants will receive vitamin D supplementation, but the dose will be known only to one investigator, who will be not be participating in any other assessment.
Primary Purpose: Prevention
Official Title: Vitamin D as a Factor Modifying Adaptation to Diverse Forms of Exercise
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Training NW
exercise and supplementation
Dietary Supplement: NW training
NW training
Other Names:
  • Training
  • vitamin D

Dietary Supplement: Placebo
training with placebo
Other Name: Control group

Experimental: Training HICT and vitamin D
Training HICT plus vitamin D
Dietary Supplement: NW training
NW training
Other Names:
  • Training
  • vitamin D

Dietary Supplement: Placebo
training with placebo
Other Name: Control group

Dietary Supplement: HICT
Training and vitamin D
Other Name: resistance training

Experimental: Placebo
placebo Vitamin D
Dietary Supplement: NW training
NW training
Other Names:
  • Training
  • vitamin D




Primary Outcome Measures :
  1. The influence of vitamin D on physical performance in aging people [ Time Frame: Values at baseline will be compared to values recorded 12 weeks and 3 months after the training programme. ]
    To verify if training supported by vitamin D supplementation will bring better effects



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

no illness medical check

Exclusion Criteria:

uncontrolled hypertension (diastolic blood pressure over 100 mmHg), a history of cardiac arrhythmia, cardio-respiratory disorders, advanced osteoporosis, clinical diagnosis of Alzheimer's Disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417700


Locations
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Poland
University of Physical Education and Sport
Gdansk, Pomorskie, Poland, 80-336
Ziemann Ewa
Sopot, Pomorskie, Poland, 81-735
Sponsors and Collaborators
Gdansk University of Physical Education and Sport
Investigators
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Principal Investigator: Ewa Ziemann Gdansk University of Physical Education and Sport, Poland
Publications of Results:

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Responsible Party: Robert Olek, Associate Professor, Gdansk University of Physical Education and Sport
ClinicalTrials.gov Identifier: NCT03417700    
Other Study ID Numbers: 2014/15/B/NZ7/00976
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Written-up results of research will be submitted for publication to international journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Olek, Gdansk University of Physical Education and Sport:
vitamin D
exercise
training
aging
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents