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Completed

NCT Number: NCT03918785

Rice Germ Supplementation on Swimmers

In order to enhance the effects of training and improve performance, athletes often turn to nutritional supplements. According to the American College of Sports Medicine (ACSM), adequate selection of nutrients and supplements, adjusting intake according to the exercise performed, is necessary for optimal performance in athletes. The most recent consensus from the International Society for Sport Nutrition (ISSN), The American Dietetic Association (ADA) and ACSM on sport nutrition have been reviewed by Potgieter, stating that a single guideline is not sufficient to elaborate an individualized and focused nutritional management of athletes. Moreover, apart from the abovementioned guidelines, sport-specific nutritional strategies, including quantity, structure and timing of food (or supplement) intake should also be followed in order to maximize sports performance and recovery. The importance of dietary supplementation is of particular interest in swimming, where athletes usually undertake a training approach characterized by a high volume of training during aerobic development and high intensity training during the competition phase, coupled with strength training.

The size and market value of the sports supplement industry is continuing to grow, with health, safety and contamination concerns becoming more pressing. Therefore, it is important to identify dietary supplements that are safe and effective in supporting swimmers. Rice germ could be a safe and effective dietary supplement for swimmers. In the last few years, scientific research is trying to use waste rice products in the pharmaceutical and nutraceutical fields, considering the potential value of nutrients they contain. In particular, rice germ has a high protein and essential amino acids, such as lysine, histidine and valine content, a good lipid content (with prevalence of mono- unsaturated and polyunsaturated fatty acids - in particular linoleic and linolenic essential fatty acids and oleic acid), an high fiber presence; regarding water-soluble vitamins, rice germ has high content if thiamine (B1) and pyridoxine (B6), while vitamin E prevails for liposoluble vitamins. About minerals, are most present iron and magnesium. All these nutrients play important roles in maintaining the health of athletes. Currently, despite these characteristics, no study has evaluated the potential beneficial effect of RG supplementation on athletes. Given this background, the purpose of this investigation was to ascertain whether performance in swimmers could be improved by a 5-weeks of RG supplementation.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderately trained athletes
  • regularly involved in regional and national competitions

Exclusion criteria

  • No history of cardiac or respiratory disease
  • no medication at the time of the study
  • no abnormalities on physical examination or on resting electrocardiogram

Treatment and study plan

Rice germ

Dietary Supplement

25 g twice a day.

Wheat-based supplement

Dietary Supplement

25g twice a day.

Primary outcomes

  1. Performance change

    Time frame: At baseline and after 5 weeks of supplementation

    Whether the performance in 50m, 200m, is improved in a 25m swimming pool in front crawl at maximal speed. Performance measured in seconds.

  2. Lactic acid production change

    Time frame: At baseline and after 5 weeks

    Capillary blood samples were collected from the fingertip before and after each swimming (at the 1st and 3rdmin of recovery) to access the higher values of blood lactate concentration (AccutrendLactate®Roche, Germany).

Secondary outcomes

  1. Antropometric measures change (skinfolds)

    Time frame: At baseline and after 5 weeks of supplementation

    skinfolds thicknesses (mm) (biceps, triceps, suprailiac, subscapular), measured twice using a Harpenden skinfold caliper at 5 min intervals at each site

  2. Body weight change (kg)

    Time frame: At baseline and after 5 weeks of supplementation

    Change in body weight (kg).

  3. Antropometric measures change (circumferences)

    Time frame: At baseline and after 5 weeks of supplementation

    Waist circumference (cm), hip circumference (cm), mid-arm circumference (cm).

  4. Change in Total fat mass, total free fat mass and visceral adipose tissue (DXA)

    Time frame: At baseline and after 5-weeks of supplementation

    Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured at baseline by DXA, using a Lunar Prodigy DEXA (GE Medical Systems, Waukesha, WI). Free Fat mass, Fat mass and visceral fat (kg) data were derived from DXA using the DXA Prodigy enCORE software (version 17; GE Healthcare).

  5. Body composition parameters change (BIVA)

    Time frame: At baseline and after 5-weeks of supplementation

    Body composition analyzed with BIVA: free fat mass, fat mass, body cellular mass change (kg).

  6. Hydration parameters change (BIVA)

    Time frame: At baseline and after 5-weeks of supplementation

    Hydration analyzed with BIVA: total body water, extracellular water, intracellular water change (L)

  7. Registration of adverse effects

    Time frame: After 7 days, 14 days, 21 days, 28 days from baseline and after 5 weeks.

    Adverse effects recorded, through phone call

  8. Muscle function change

    Time frame: At baseine and after 5 weeks.

    The JAMAR Hand Dynamometer (Jamar 5030J1; Sammons Preston Rolyan; accuracy 0.6 N) was used to assess muscle function with the use of a standardized procedure(Spijkerman, Dorine C., Snijders, Chris J., Stijnen, Theo, & Lankhorst 1991). Handgrip measured in kilograms.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Rice Germ Supplementation on Moderately Trained Swimmers: a Randomized Pilot Clinical Trial

Acronym: RGS swimmers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 18, 2019
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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