Trial document




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  DRKS00014322

Trial Description

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Title

Physical Activity, Nutrition and Health: Influence of a training and nutritional intervention on health-related parameters of yet physically inactive people

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Trial Acronym

BEGinn

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Nutrition and exercise both have many effects on health, well-being and also play a crucial role in the prevention of chronic degenerative diseases. Present data shows that physical activity not only counteracts the age-related muscle and bone mineral loss but may also lead to immunological improvements. However, it remains unclear to which extent physically inactive people may benefit from this and which impact additional nutritional measures might have. Therefore, the aim of the “BEGinn” study was to investigate the effect of a training program alone or in combination with a wholesome diet or the administration of omega-3 fatty acids on immunological, nutritional and scientific sports parameters. A waiting-control group will receive the intervention after a waiting period of 12 weeks.

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Brief Summary in Scientific Language

Despite a weakened immune defense, there is an increased inflammatory activity in the elderly.This is discussed as a causative factor in the development of a variety of degenerative diseases, such as diabetes mellitus or cardiovascular diseases. Age-related immunological changes, which have been shown to be associated with increased morbidity and mortality, are described by the Immune Risk Profile (IRP). The IRP encompasses a reduced ratio of CD4 + / CD8 + T-cells, a moderate increase in pro-inflammatory cytokines in the blood, an accumulation of senescent T-cells and a reduction in naive T-cells. It was shown that physical activity as well as nutritional measures can both slow the process of immune senescence down and even partially reverse it. Interestingly, studies that investigated the impact of diet and physical activity on immunocompenence in the elderly have only focused on one of both components. The aim of the BEGinn study is to examine the effect of a twelve-week training program alone or in combination with a wholesome diet or the administration of omega-3 fatty acids on immunological, nutritional and scientific sports parameters.

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Organizational Data

  •   DRKS00014322
  •   2018/03/28
  •   [---]*
  •   yes
  •   Approved
  •   Bo/07/2018, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Physical inactivity
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Interventions/Observational Groups

  •   Sports intervention: Includes the independent performance of a standardized fitness circle in cooperating fitness centers, twice a week for 12 weeks.
  •   Sports and nutritional intervention: Includes the independent performance of a standardized fitness circle in cooperating fitness centers, twice a week for 12 weeks and an individual nutrition counselling. The nutritional advice will be in accordance with the guidelines of the German Nutrition Association (Deutsche Gesellchaft für Ernährung, DGE)
  •   Sports intervention and intake of multivitamin mineral preparation: Includes the independent performance of a standardized fitness circle in cooperating fitness centers, twice a week for 12 weeks and and the daily intake of omega-3 fatty acids.
  •   Waiting-control group: this group will start the intervention according to groups 1-3 after a waiting period of 12 weeks. The assignment of the subjects to the groups is done by randomization.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Determination of the CD4 / CD8 ratio of T-cells in venous blood at the beginning and at the end of the twelve-week intervention.

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Secondary Outcome

At the beginning and end of the intervention, the following parameters will be determined from venous blood:
- i.a. immunological parameters, e.g. number of regulatory T-cells, T-cell apoptosis and activation markers (Annexin V and CD69)
- i.a. biochemical parameters (e.g., parameters of iron metabolism, vitamin B12 (cobalamin)),
- i.a. Health status survey (e.g., SF36)
- i.a. Survey of diet and exercise behavior (e.g., FFQ, Freiburger Fragebogen questionnaire on physical activity)
- anthropometric data

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/08/13
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   70   Years
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Additional Inclusion Criteria

- consent men and women
- 50 - 70 years
- so far physically inactive people who have not carried out specific sports activities outside of their daily activities for at least 2 years
- sports capability
- willingness to independently perform a training program for 12 weeks
- willingness to implement given dietary recommendations in everyday life
- willingness to take a multivitamin mineral preperation daily for 12 weeks
- willingness to be assigned to the waiting control group and to receive the intervention after a waiting period of 12 weeks
- stable weight since min. half a year (± 5 kg)
- omnivorous diet

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Exclusion Criteria

- severe chronic diseases (cancer, type 1 diabetes, etc.), manifest cardiovascular diseases, renal insufficiency, liver disease
- chronic diseases of the gastrointestinal tract (e.g., ulcerative colitis, Crohn's disease, pancreatic insufficiency)
- blood coagulation disorders
- known immunological disorders (e.g., autoimmune diseases)
- regular intake of laxatives
- permanent use of immunosuppressive drugs (cortisone, anti-inflammatory drugs, non-steroidal anti-inflammatory drugs, etc.)
- drug, alcohol and medication abuse
- non-consenting subjects
- simultaneous participation in another clinical study or participation within the past 30 days
- ingestion of mineral and / or vitamin supplements, unless discontinued 6-8 weeks prior to study

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Addresses

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    • Institut für Lebensmittelwissenschaft und Humanernährung
    • Mr.  Prof. Dr.  Andreas  Hahn 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Institut für Sportwissenschaft, Abteilung für Sport und Gesundheit
    • Mr.  Prof. Dr.  Karsten  Krüger 
    • Am Moritzwinkel 6
    • 30167  Hannover
    • Germany
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    • Institut für Lebensmittelwissenschaft und Humanernährung
    • Ms.  Paulina  Wasserfurth 
    • Am Kleinen Felde 30
    • 30161  Hannover
    • Germany
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    • Institut für Sportwissenschaft, Abteilung für Sport und Gesundheit
    • Mr.  Tim Konstantin  Boßlau 
    • Am Moritzwinkel 6
    • 30167  Hannover
    • Germany
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    • Institut für Lebensmittelwissenschaft und Humanernährung
    • Ms.  Paulina  Wasserfurth 
    • Am Kleinen Felde 30
    • 30161  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Lebensmittelwissenschaft und Humanernährung
    • Mr.  Prof. Dr.  Andreas  Hahn 
    • Am Kleinen Felde 30
    • 30161  Hannover
    • Germany
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    • Institut für Sportwissenschaft, Abteilung für Sport und Gesundheit
    • Mr.  Prof. Dr.  Karsten  Krüger 
    • Am Moritzwinkel 6
    • 30167  Hannover
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.