RGS swimmers: Rice Germ Supplementation on Swimmers

Sponsor
Azienda di Servizi alla Persona di Pavia (Other)
Overall Status
Completed
CT.gov ID
NCT03918785
Collaborator
(none)
27
2
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Rice germ
  • Dietary Supplement: Wheat-based supplement
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Rice Germ Supplementation on Moderately Trained Swimmers: a Randomized Pilot Clinical Trial
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 30, 2014
Actual Study Completion Date :
Dec 31, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Performance change [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 [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 Outcome Measures

  1. Antropometric measures change (skinfolds) [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) [At baseline and after 5 weeks of supplementation]

    Change in body weight (kg).

  3. Antropometric measures change (circumferences) [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) [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) [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Azienda di Servizi alla Persona di Pavia

Investigators

  • Study Director: Mariangela Rondanelli, MD, PhD, Professor, Mariangela Rondanelli, IRCCS Mondino Foundation, Pavia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mariangela Rondanelli, Principal Investigator, Azienda di Servizi alla Persona di Pavia
ClinicalTrials.gov Identifier:
NCT03918785
Other Study ID Numbers:
  • 1114/06072014
First Posted:
Apr 18, 2019
Last Update Posted:
Apr 22, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mariangela Rondanelli, Principal Investigator, Azienda di Servizi alla Persona di Pavia

Study Results

No Results Posted as of Apr 22, 2019