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van CCT (UK)

van CCT (UK)

The Impact of Fish Oil Supplementation on Muscle Growth in Older Men

- candidate number24371
- NTR NumberNTR5885
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2016
- Secondary IDs2016-1646-GRA N/A
- Public TitleThe Impact of Fish Oil Supplementation on Muscle Growth in Older Men
- Scientific TitleThe impact of n-3 PUFA supplementation on daily muscle protein synthesis rates in older men
- ACRONYMn-3 PUFA and muscle protein synthesis
- hypothesis4 week n-3 PUFA supplementation will enhance daily muscle protein synthesis rates in older men on a standardized diet.
- Healt Condition(s) or Problem(s) studiedSarcopenia
- Inclusion criteria1) Male
2) Age 65-80 y
3) BMI between 18.5 and 30 kg/m2
4) Generally healthy as assessed by medical questionnaire
5) Willing and able to provide informed consent
- Exclusion criteria1) Medical, orthopedic, or psychiatric concern that, in the opinion of the investigators, would compromise the ability to comply with the study requirements
2) History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
3) Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would affect protein metabolism
4) Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea or regurgitation)
5) Subject participated in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study
6) Excessive alcohol consumption (>21 units/week)
7) Smoking
8) Prior gastrointestinal bypass surgery
9) History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy
10) Use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid
11) Participation in an exercise program
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate31-jan-2018
- Target number of participants13
- InterventionsThe experimental trial consists of two 5-d phases separated by 4 weeks of supplementation. Muscle protein synthesis will be determined during the last 2 d of each 5-d phase. For each phase, dietary intake will be controlled to provide an energy balanced diet containing 1.0 g of protein per kg body weight per day equally distributed over breakfast, lunch, and dinner. Participants will be instructed to refrain from vigorous-intensity physical activity (running, fast cycling, competitive sports, carrying heavy loads, etc.) and refrain from alcohol consumption for 3 d prior to and during the 2 d of measuring muscle protein synthesis. Participants will wear an accelerometer to monitor physical activity on the day before and the 2 d of measuring muscle protein synthesis. On day 3, a blood and saliva sample as well as muscle biopsy will be obtained in the fasted state and participants will then consume 150 mL deuterated water (D2O). The subsequent day (day 4), another saliva sample and muscle biopsy will be obtained to assess body water and muscle protein deuterium enrichments. An oral glucose tolerance test (OGTT) will be performed to assess insulin sensitivity. 48 h after D2O consumption, a saliva sample and the third muscle biopsy will be obtained to determine muscle protein synthesis rates.

On day 6, daily n-3 PUFA supplementation will be initiated. Participants will consume 5 g of n-3 PUFA-enriched fish oil capsules per day containing 3.5 g EPA and 0.9 g DHA. One blood sample per week will be obtained to assess blood lipid composition and plasma markers of inflammatory state. After 4 weeks of supplementation, the 5-d phase will be repeated.
- Primary outcomeDaily muscle protein synthesis rates assessed using D2O before and after 4 weeks of fish oil supplementation
- Secondary outcome1) Muscle and blood lipid composition before, during, and after fish oil supplementation
2) Plasma markers of inflammatory state before, during, and after fish oil supplementation
3) Insulin sensitivity as assessed by oral glucose tolerance test following the ingestion of 75 g glucose before and after 4 weeks of fish oil supplementation
- TimepointsBefore and after 4 weeks of n-3 PUFA supplementation
- Trial web siteN/A
- statusplanned
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Stuart Philips
- Sponsor/Initiator McMaster University
- Funding
(Source(s) of Monetary or Material Support)
McMaster University
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-mei-2016 - 6-jul-2016

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