Rice Germ Supplementation on Swimmers (RGS swimmers)

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

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.

Study Overview

• Status: Completed
• Conditions: Athletes; Sports
• Intervention / Treatment: Dietary supplement: Rice germ; Dietary supplement: Wheat-based supplement

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rice Germ; The Rice Germ was supplied in vacuum jars of a weight of 130 grams. These jars once opened, were stored in the refrigerator (-3-4°C). Together with cans, small containers were provided to act as dosers and served to determine the correct dose to be taken (25 grams, twice a day). The rice germ or placebo were continually taken every day twice a day (25 grams in the morning with breakfast and 25 grams in the afternoon as snacks) for 5 weeks. The rice germ was supplied by the company "Acquerello" (TenutaColombara, Livorno Ferraris, Vercelli, Italy).	Dietary supplement: Rice germ; 25 g twice a day.
Active Comparator: Control group; Active comparator, which consisted of an isocaloric wheat germ-based supplement. Characteristics of supplementation are the same of experimental group.	Dietary supplement: Wheat-based supplement; 25g twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Body weight change (kg)	Change in body weight (kg).	At baseline and after 5 weeks of supplementation
Antropometric measures change (circumferences)	Waist circumference (cm), hip circumference (cm), mid-arm circumference (cm).	At baseline and after 5 weeks of supplementation
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
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
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
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.
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.

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Study Director: Mariangela Rondanelli, MD, PhD, Professor, Mariangela Rondanelli, IRCCS Mondino Foundation, Pavia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): June 30, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 14, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: fat free mass; nutritional supplement; lactic acid; swimmers; rice germ
• Other Study ID Numbers: 1114/06072014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No