NCT03918785

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

March 27, 2019

Last Update Submit

April 18, 2019

Conditions

Keywords

rice germswimmersnutritional supplementlactic acidfat free mass

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Antropometric measures change (skinfolds)

    At baseline and after 5 weeks of supplementation

  • Body weight change (kg)

    At baseline and after 5 weeks of supplementation

  • Antropometric measures change (circumferences)

    At baseline and after 5 weeks of supplementation

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

    At baseline and after 5-weeks of supplementation

  • Body composition parameters change (BIVA)

    At baseline and after 5-weeks of supplementation

  • +3 more secondary outcomes

Study Arms (2)

Rice Germ

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Rice germDIETARY_SUPPLEMENT

25 g twice a day.

Rice Germ
Wheat-based supplementDIETARY_SUPPLEMENT

25g twice a day.

Control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mariangela Rondanelli, MD, PhD, Professor

    Mariangela Rondanelli, IRCCS Mondino Foundation, Pavia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 18, 2019

Study Start

April 1, 2014

Primary Completion

June 30, 2014

Study Completion

December 31, 2014

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share