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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03918785
Other study ID # 1114/06072014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2014
Est. completion date December 31, 2014

Study information

Verified date April 2019
Source Azienda di Servizi alla Persona di Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 31, 2014
Est. primary completion date June 30, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Rice germ
25 g twice a day.
Wheat-based supplement
25g twice a day.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Azienda di Servizi alla Persona di Pavia

Outcome

Type Measure Description Time frame Safety issue
Primary Performance change Whether the performance in 50m, 200m, is improved in a 25m swimming pool in front crawl at maximal speed. Performance measured in seconds. At baseline and after 5 weeks of supplementation
Primary Lactic acid production change 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). At baseline and after 5 weeks
Secondary Antropometric measures change (skinfolds) skinfolds thicknesses (mm) (biceps, triceps, suprailiac, subscapular), measured twice using a Harpenden skinfold caliper at 5 min intervals at each site At baseline and after 5 weeks of supplementation
Secondary Body weight change (kg) Change in body weight (kg). At baseline and after 5 weeks of supplementation
Secondary Antropometric measures change (circumferences) Waist circumference (cm), hip circumference (cm), mid-arm circumference (cm). At baseline and after 5 weeks of supplementation
Secondary Change in Total fat mass, total free fat mass and visceral adipose tissue (DXA) 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). At baseline and after 5-weeks of supplementation
Secondary Body composition parameters change (BIVA) Body composition analyzed with BIVA: free fat mass, fat mass, body cellular mass change (kg). At baseline and after 5-weeks of supplementation
Secondary Hydration parameters change (BIVA) Hydration analyzed with BIVA: total body water, extracellular water, intracellular water change (L) At baseline and after 5-weeks of supplementation
Secondary Registration of adverse effects Adverse effects recorded, through phone call After 7 days, 14 days, 21 days, 28 days from baseline and after 5 weeks.
Secondary Muscle function change 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. At baseine and after 5 weeks.
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