Clinical trial NCT03918785: Rice Germ Supplementation on Swimmers
Official title: Rice Germ Supplementation on Moderately Trained Swimmers: a Randomized Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletes
Sports
Keywords: rice germ
swimmers
nutritional supplement
lactic acid
fat free mass
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance change
timeFrame: At baseline and after 5 weeks of supplementation
measure: Lactic acid production change
timeFrame: At baseline and after 5 weeks
Secondary outcomes:
measure: Antropometric measures change (skinfolds)
timeFrame: At baseline and after 5 weeks of supplementation
measure: Body weight change (kg)
timeFrame: At baseline and after 5 weeks of supplementation
measure: Antropometric measures change (circumferences)
timeFrame: At baseline and after 5 weeks of supplementation
measure: Change in Total fat mass, total free fat mass and visceral adipose tissue (DXA)
timeFrame: At baseline and after 5-weeks of supplementation
measure: Body composition parameters change (BIVA)
timeFrame: At baseline and after 5-weeks of supplementation
measure: Hydration parameters change (BIVA)
timeFrame: At baseline and after 5-weeks of supplementation
measure: Registration of adverse effects
timeFrame: After 7 days, 14 days, 21 days, 28 days from baseline and after 5 weeks.
measure: Muscle function change
timeFrame: At baseine and after 5 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Mariangela Rondanelli, IRCCS Mondino Foundation, Pavia
name: Mariangela Rondanelli, MD, PhD, Professor
role: STUDY_DIRECTOR
References: