AthletesRGS swimmersNCT03918785
Rice Germ Supplementation on Swimmers
A study testing Rice germ and Wheat-based supplement in people with Athletes and Sports, run by Azienda di Servizi alla Persona di Pavia.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Rice germ and Wheat-based supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- moderately trained athletes
- regularly involved in regional and national competitions
Who cannot join
- No history of cardiac or respiratory disease
- no medication at the time of the study
- no abnormalities on physical examination or on resting electrocardiogram
About this study
Official title: 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.
- Being tested
- Rice germ, Wheat-based supplement
- Keywords
- rice germ, swimmers, nutritional supplement, lactic acid, fat free mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice germDietary supplement
25 g twice a day.
Wheat-based supplementDietary supplement
25g twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: Wheat-based supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At baseline and after 5 weeks
Secondary outcomes (8)
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
Measured: At baseline and after 5 weeks of supplementation
Body weight change (kg)
Change in body weight (kg).
Measured: At baseline and after 5 weeks of supplementation
Antropometric measures change (circumferences)
Waist circumference (cm), hip circumference (cm), mid-arm circumference (cm).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: At baseline and after 5-weeks of supplementation
Registration of adverse effects
Adverse effects recorded, through phone call
Measured: 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.
Measured: At baseine and after 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Apr 2014
- Primary completion30 Jun 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Rondanelli, Azienda di Servizi alla Persona di Pavia
- Investigators
- Mariangela Rondanelli, MD, PhD, Professor, Study director, Mariangela Rondanelli, IRCCS Mondino Foundation, Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918785
- Sponsor's protocol ID
- 1114/06072014
- Acronym
- RGS swimmers
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rice Germ Supplementation on Moderately Trained Swimmers: a Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03918785
- Acronym / sponsor ID
- RGS swimmers / 1114/06072014
- Keywords
- rice germ, swimmers, nutritional supplement, lactic acid, fat free mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice Germ | Experimental | Dietary Supplement: Rice germThe 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). |
| Control group | Active comparator | Dietary Supplement: Wheat-based supplementActive comparator, which consisted of an isocaloric wheat germ-based supplement. Characteristics of supplementation are the same of experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- moderately trained athletes
- regularly involved in regional and national competitions
Key exclusion criteria (3 listed)
- No history of cardiac or respiratory disease
- no medication at the time of the study
- no abnormalities on physical examination or on resting electrocardiogram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rice germ25 g twice a day. | Dietary supplement | Rice Germ |
| Wheat-based supplement25g twice a day. | Dietary supplement | Control group |
Primary outcome
Performance change
Time frame: 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.
Lactic acid production change
Time frame: 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).
8 secondary outcomes
Antropometric measures change (skinfolds)
Time frame: At baseline and after 5 weeks of supplementation
Body weight change (kg)
Time frame: At baseline and after 5 weeks of supplementation
Antropometric measures change (circumferences)
Time frame: At baseline and after 5 weeks of supplementation
Change in Total fat mass, total free fat mass and visceral adipose tissue (DXA)
Time frame: At baseline and after 5-weeks of supplementation
Body composition parameters change (BIVA)
Time frame: At baseline and after 5-weeks of supplementation
Hydration parameters change (BIVA)
Time frame: At baseline and after 5-weeks of supplementation
Registration of adverse effects
Time frame: After 7 days, 14 days, 21 days, 28 days from baseline and after 5 weeks.
Muscle function change
Time frame: At baseine and after 5 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Athletes
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
RecruitingObservational study
Bone Stress Injury Recovery and Return to Sport: A Natural History Study
Bone Stress Fracture
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruiting
Comparison Between Eccentric Hamstring Training and Sprint-Specific Training
Healthy Adult, Athlete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariangela Rondanelli, MD, PhD, Professor study director
Mariangela Rondanelli, IRCCS Mondino Foundation, Pavia
Questions about this trial
What is this clinical trial studying?
A study testing Rice germ and Wheat-based supplement in people with Athletes and Sports, run by Azienda di Servizi alla Persona di Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance change (time frame: At baseline and after 5 weeks of supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.