- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02014233
Short Term Omega-3 Supplementation on Performance
The Effect of Short Term Omega-3 Supplementation on Exercise Performance and Neuromuscular Function.
연구 개요
상세 설명
Participants will come to the lab for 3 sessions, one for familiarization and two for testing.
Familiarization - At this time, anthropometric measurements including height, weight, BMI (body mass index) and body composition will be determined. Participants will be familiarized with the interpolated twitch technique and performing a maximal voluntary contraction of the quadriceps muscle. Next, Participant's 10 repetition maximum squat weight will be established by starting at a participant selected weight and gradually increasing until only 10 squat repetitions can be completed. A VO2max (maximum oxygen consumption) test will be performed on a cycle ergometer using standard methods.
On testing sessions 1 and 2 the following neuromuscular and performance measures will be evaluated:
Quadriceps muscle voluntary activation will be assessed using the interpolated twitch technique and doublet twitch technique. Participants will be seated and instructed to perform three 5 second maximal voluntary isometric contractions at least 1 minute apart - participant's ankle will be restrained by a padded cuff attached to a load cell.
For the second maximal isometric contraction at 3 seconds into the contraction, a square wave superimposed stimulus will be delivered for 1 milliseconds to the femoral nerve from a monopolar touch-proof cathode electrode secured in the femoral triangle. 2, 7 and 12 seconds after the contraction a resting twitch will be delivered for comparison of muscle force.
For the third maximal isometric contraction, at 3 seconds into the contraction, two 1 millisecond square wave superimposed stimuli at 100 Hz will be delivered 10 milliseconds apart. 2 seconds after the contraction the same stimulus will be applied. At 7 seconds after, two stimuli will be delivered 100 milliseconds at 10 Hz apart and 12 seconds after a single stimulus will be delivered.
The percutaneous electrical stimulation will be delivered from a Biopac stimulator (BSLSTMA, Biopac Systems, Santa Barbara, California) with a maximum voltage of 400 V. During familiarization, participants will receive several submaximal stimulations for acclimatization before the current intensity is gradually increased until peak twitch torque and muscle action potential amplitude is reached. A stimulus of 1.2 times the current required to elicit peak twitch torque and action potential amplitude will be used to ensure maximal activation. The interpolated twitch technique will be used to examine the difference in muscle activation during maximal contraction and a superimposed stimulation. Voluntary activation will be calculated using the formula:
Voluntary activation (%) = (1- superimposed twitch / twitch evoked at rest) x 100
Surface self-adhesive silver chloride electrodes will be placed over the belly of the vastus lateralis, vastus medialis and biceps femoris muscles to measure muscle electrical activity (electromyography) during maximal voluntary contractions as previously described.
- Vertical jump - Quadriceps power will be assessed using the vertical jump test on a force plate (AMTI, Watertown, Massachusetts, USA). Participants will complete two attempts to jump as high as possible from crouched and two attempts using the counter jump technique (participants can start from standing, bend the knees and then jump).
- Push-up - Upper body strength endurance will be examined by having the participant complete as many push-ups as possible in one-minute. Participants will be given one-minute rest before being asked to complete as many push-ups as possible in a minute. A piece of soft foam will be attached to the floor to provide participants feedback as to how low the must go when performing each push-up.
- 10RM (10 repetition maximum) squat - After completing an optional 2 to 4 repetitions of 75% of the their 10RM weight as determined during baseline data collection, participants will complete as many repetitions as possible.
- Wingate test - Participants will be fitted to a cycle ergometer (Excalibur Sport V2.0, Lode, Groningen, The Netherlands). They will then cycle against a fixed resistance of 0.075kg / kg body mass for 30 seconds using their maximum effort. Verbal encouragement will be provided to the participant to help produce their maximum effort.
- Cycling time trial - Participants will complete a 10km time trial on a cycle ergometer (Excalibur Sport V2.0, Lode, Groningen, The Netherlands). Participants' inspired and expired gasses will be measured using a metabolic cart (Cortex, Leipzig, Germany). Gas variables and cycling power output will be measured using the supplied software. This change in protocol does not alter the risk to participants as their level of conditioning is quite high and similar levels of exertion would be required in their daily training.
Supplementation - In between sessions 1 and 2, there is a 21 day break for which participants will be computer randomized to either the omega-3 supplementation or an olive oil placebo. Participants will take a 2.5 mL serving of seal oil (2500 mg n-3, 255 mg DHA (docosahexaenoic acid ) and 187.5 mg EPA (eicosapentaenoic acid) with 500 IU vitamin D3 and 1000 IU vitamin A) (Auum Inc., Timmons, On) or 2.5 mL olive oil (Bertolli, Mississauga, Ont) with 500 IU vitamin D and 1000 IU vitamin A added twice daily with breakfast and dinner.
All supplementation amounts are within the amounts specified by Health Canada Guidelines.
Session 2 - After the 21 day supplementation period, participants will return to the lab for a second evaluatory session using identical protocols to session 1.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ontario
-
Toronto, Ontario, 캐나다, M5S 3E2
- University of Toronto
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 2 years training experience that includes resistance training, specifically back squat
- Successfully completing a Par-Q questionnaire
Exclusion Criteria:
- Individuals that have or are currently taking an omega-3 and/or omega-6 supplement within 4 weeks of the study
- Individuals that have taken mammalian based omega-3 or 6 supplements in the past 6 months
- Individuals consuming fish more than twice per week within 4 weeks of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Omega-3
Participants will consume 5 mL of omega-3 (2333 mg essential fatty acids) with 1000 IU vitamin D3 for 21 days.
|
다른 이름들:
|
|
위약 비교기: Olive oil
Participants will consume 5 mL of olive oil with 1000 IU vitamin D3 for 21 days.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in maximum voluntary contraction force
기간: 21 days
|
Participants will be seated with their right knee fixed at 90°.
The right ankle will be restrained by a padded cuff attached in series to a load cell.
Participants will be instructed to contract their quadriceps maximally by trying to extending their leg.
The load cell will measure the maximum force produced.
|
21 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in vertical jump height
기간: 21 days
|
Participants will perform both squat jumps and counter movement jumps on a force plate.
Jump height (cm) will be measured.
|
21 days
|
|
Change from baseline in number of push-ups
기간: 21 days
|
Participants will perform the maximum number of push-ups possible in one minute while maintaining proper form.
A one minute rest will be given and then they will repeat the same procedure.
|
21 days
|
|
Change from baseline in number of 10RM squats
기간: 21 days
|
Participants will complete as many reps of back squats possible using the 10 repetition maximum weight established during familiarization.
|
21 days
|
|
Change from baseline in Wingate test peak power
기간: 21 days
|
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight.
Peak power, average power, fatigue index and cadence will all be measured.
|
21 days
|
|
Change from baseline in 250 kJ cycling time trial time to completion
기간: Baseline and 21 days
|
Participants will complete 250 kJ (kilo Joules) of cycling on an ergometer which is equivalent to 10km.
Time to completion and average power (Watts) will be measured.
|
Baseline and 21 days
|
|
Change from baseline in Pre/Post maximal voluntary contraction force
기간: 21 days
|
Pre/Post quadriceps maximal voluntary contraction force is the difference in maximal voluntary contraction force measured at the beginning and end of each testing session to determine changes in neuromuscular function as a result of the other fatiguing tests.
|
21 days
|
|
Change from baseline in quadriceps voluntary activation
기간: 21 days
|
Participants femoral nerve will be electrically stimulated during the maximal voluntary contraction.
Voluntary activation is the difference in muscle force output between the voluntary contraction and the electrically stimulated contraction.
|
21 days
|
|
Change from baseline in Wingate test average power
기간: 21 days
|
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight.
Peak power, average power, fatigue index and cadence will all be measured.
|
21 days
|
|
Change from baseline in Wingate test fatigue index
기간: 21 days
|
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight.
Peak power, average power, fatigue index and cadence will all be measured.
|
21 days
|
|
Change from baseline in Wingate test cadence
기간: 21 days
|
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight.
Peak power, average power, fatigue index and cadence will all be measured.
|
21 days
|
|
Change from baseline in 250 kJ cycling time trial average power
기간: Baseline and 21 days
|
Participants will complete 250 kJ of cycling on an ergometer which is equivalent to 10km.
Time to completion and average power (Watts) will be measured.
|
Baseline and 21 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas MS Wolever, MD, PhD, University of Toronto
간행물 및 유용한 링크
일반 간행물
- Rodacki CL, Rodacki AL, Pereira G, Naliwaiko K, Coelho I, Pequito D, Fernandes LC. Fish-oil supplementation enhances the effects of strength training in elderly women. Am J Clin Nutr. 2012 Feb;95(2):428-36. doi: 10.3945/ajcn.111.021915. Epub 2012 Jan 4.
- MERTON PA. Voluntary strength and fatigue. J Physiol. 1954 Mar 29;123(3):553-64. doi: 10.1113/jphysiol.1954.sp005070. No abstract available.
- Millet GY, Tomazin K, Verges S, Vincent C, Bonnefoy R, Boisson RC, Gergele L, Feasson L, Martin V. Neuromuscular consequences of an extreme mountain ultra-marathon. PLoS One. 2011 Feb 22;6(2):e17059. doi: 10.1371/journal.pone.0017059.
- Presland JD, Dowson MN, Cairns SP. Changes of motor drive, cortical arousal and perceived exertion following prolonged cycling to exhaustion. Eur J Appl Physiol. 2005 Sep;95(1):42-51. doi: 10.1007/s00421-005-1395-3. Epub 2005 Jun 23.
- Behm DG, St-Pierre DM, Perez D. Muscle inactivation: assessment of interpolated twitch technique. J Appl Physiol (1985). 1996 Nov;81(5):2267-73. doi: 10.1152/jappl.1996.81.5.2267.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- UTTW-N3-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
근력에 대한 임상 시험
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
올리브유에 대한 임상 시험
-
Zhejiang Kanglaite Pharmaceutical Co.LtdLinkDoc Technology (Beijing) Co. Ltd.; NanJing PLA 81 Hospital알려지지 않은
-
Peter Bergman완전한
-
Mario Negri Institute for Pharmacological Research모병염증 | 지질 | 심혈관 질환 | n-3 다중불포화 지방산 (n-3 PUFA)이탈리아
-
Thomas Jefferson University모집하지 않고 적극적으로
-
University of Duhok완전한