HealthyNCT00794079
Omega-3 Fatty Acids and Muscle Protein Synthesis
A study testing omega-3 fatty acids and corn oil in people with Healthy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- omega-3 fatty acids and corn oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2010
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) < 30 kg/m2;
- Age 18-45 yr; or
- Age 65-85 yr
Who cannot join
- Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.);
- Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo- or hyperthyroidism; hypertension);
- Body mass index > 30 kg/m2
- Age <18 yr, 45-65 yr or > 85 yr
- Those performing >1.5h of exercise/wk
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.
Read the detailed description
Loss of muscle mass is a normal consequence of aging. The decline in muscle mass is estimated to be 0.2-0.5% per year from 60 years old onwards in healthy subjects with the decline worsened by chronic illness, poor appetite and diet, and reduced physical activity in the elderly. Increased morbidity is demonstrable with as little as a 5% loss of muscle mass - therefore, treatments that can prevent or slow the progression of muscle loss with aging are much desired.
A major cause for loss of muscle mass in advanced age appears to be an impaired ability to stimulate the synthesis of muscle protein in response to increased levels of amino acids (the building blocks of proteins) and insulin as occurs after eating because of low-grade inflammation and insulin resistance in muscle of old persons. We propose that long-chain omega-3 polyunsaturated fatty acids (fish oil) slow the loss of muscle mass because fish oil has anti-inflammatory properties and increases the sensitivity of muscle protein synthesis to insulin and amino acids. We will test this by studying the effect of fish oil supplementation on the muscle protein synthesis process in young and older adults.
- Conditions
- Healthy
- Being tested
- omega-3 fatty acids, corn oil
- Keywords
- Healthy volunteers, young adults, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidsDietary supplement
Also called Lovaza
4 grams per day for 8 weeks
corn oilDietary supplement
4 grams per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | omega-3 fatty acids Receives: Dietary Supplement: omega-3 fatty acids |
| B | Placebo comparator | corn oil Receives: Dietary Supplement: corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of omega-3 fatty acid supplementation on skeletal muscle protein synthesis rates both in the basal, postabsorptive state and in response to infusion of insulin and amino acids in young and older adults
Measured: Measurements taken prior to and following 8 weeks of supplementation
Secondary outcomes (3)
Evaluate the effect of omega-3 fatty acid supplementation on anabolic signaling pathways in skeletal muscle
Measured: Measurements taken prior to and following 8 weeks of supplementation
Evaluate the effect of omega-3 fatty acid supplementation on inflammatory cytokines in the systemic circulation and inflammatory signaling pathways in skeletal muscle
Measured: Measurements taken prior to and following 8 weeks of supplementation
Compare muscle protein synthesis rates between men and women in the basal, postabsorptive state and in response to insulin and amino acid infusion
Measured: prior to supplementation only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Longer Life Foundation, American Federation for Aging Research, Reliant Pharmaceuticals
- Investigators
- Bettina Mittendorfer, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794079
- Sponsor's protocol ID
- 06-1147
- Status last verified
- Aug 2011
- First submitted
- 18 Nov 2008
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial. Am J Clin Nutr. 2011 Feb;93(2):402-12. doi: 10.3945/ajcn.110.005611. Epub 2010 Dec 15.
PubMed 21159787Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Omega-3 polyunsaturated fatty acids augment the muscle protein anabolic response to hyperinsulinaemia-hyperaminoacidaemia in healthy young and middle-aged men and women. Clin Sci (Lond). 2011 Sep;121(6):267-78. doi: 10.1042/CS20100597.
PubMed 21501117Smith GI, Atherton P, Reeds DN, Mohammed BS, Jaffery H, Rankin D, Rennie MJ, Mittendorfer B. No major sex differences in muscle protein synthesis rates in the postabsorptive state and during hyperinsulinemia-hyperaminoacidemia in middle-aged adults. J Appl Physiol (1985). 2009 Oct;107(4):1308-15. doi: 10.1152/japplphysiol.00348.2009. Epub 2009 Jul 30.
PubMed 19644030
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and Muscle Protein Synthesis
- ClinicalTrials.gov ID
- NCT00794079
- Acronym / sponsor ID
- 06-1147
- Conditions
- Healthy
- Keywords
- Healthy volunteers, young adults, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Longer Life Foundation, American Federation for Aging Research, Reliant Pharmaceuticals
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Nov 2008 (estimated)
- 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.
The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.
Detailed description
Loss of muscle mass is a normal consequence of aging. The decline in muscle mass is estimated to be 0.2-0.5% per year from 60 years old onwards in healthy subjects with the decline worsened by chronic illness, poor appetite and diet, and reduced physical activity in the elderly. Increased morbidity is demonstrable with as little as a 5% loss of muscle mass - therefore, treatments that can prevent or slow the progression of muscle loss with aging are much desired.
A major cause for loss of muscle mass in advanced age appears to be an impaired ability to stimulate the synthesis of muscle protein in response to increased levels of amino acids (the building blocks of proteins) and insulin as occurs after eating because of low-grade inflammation and insulin resistance in muscle of old persons. We propose that long-chain omega-3 polyunsaturated fatty acids (fish oil) slow the loss of muscle mass because fish oil has anti-inflammatory properties and increases the sensitivity of muscle protein synthesis to insulin and amino acids. We will test this by studying the effect of fish oil supplementation on the muscle protein synthesis process in young and older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: omega-3 fatty acidsomega-3 fatty acids |
| B | Placebo comparator | Dietary Supplement: corn oilcorn oil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) < 30 kg/m2;
- Age 18-45 yr; or
- Age 65-85 yr
Key exclusion criteria (5 listed)
- Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.);
- Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo- or hyperthyroidism; hypertension);
- Body mass index > 30 kg/m2
- Age <18 yr, 45-65 yr or > 85 yr
- Those performing >1.5h of exercise/wk
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 |
|---|---|---|
| omega-3 fatty acidsAlso: Lovaza4 grams per day for 8 weeks | Dietary supplement | A |
| corn oil4 grams per day for 8 weeks | Dietary supplement | B |
Primary outcome
Evaluate the effect of omega-3 fatty acid supplementation on skeletal muscle protein synthesis rates both in the basal, postabsorptive state and in response to infusion of insulin and amino acids in young and older adults
Time frame: Measurements taken prior to and following 8 weeks of supplementation
3 secondary outcomes
Evaluate the effect of omega-3 fatty acid supplementation on anabolic signaling pathways in skeletal muscle
Time frame: Measurements taken prior to and following 8 weeks of supplementation
Evaluate the effect of omega-3 fatty acid supplementation on inflammatory cytokines in the systemic circulation and inflammatory signaling pathways in skeletal muscle
Time frame: Measurements taken prior to and following 8 weeks of supplementation
Compare muscle protein synthesis rates between men and women in the basal, postabsorptive state and in response to insulin and amino acid infusion
Time frame: prior to supplementation only
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 3 Aug 2011.
- Results publication: PubMed 21159787Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial. Am J Clin Nutr. 2011 Feb;93(2):402-12. doi: 10.3945/ajcn.110.005611. Epub 2010 Dec 15.
- Results publication: PubMed 21501117Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Omega-3 polyunsaturated fatty acids augment the muscle protein anabolic response to hyperinsulinaemia-hyperaminoacidaemia in healthy young and middle-aged men and women. Clin Sci (Lond). 2011 Sep;121(6):267-78. doi: 10.1042/CS20100597.
- Results publication: PubMed 19644030Smith GI, Atherton P, Reeds DN, Mohammed BS, Jaffery H, Rankin D, Rennie MJ, Mittendorfer B. No major sex differences in muscle protein synthesis rates in the postabsorptive state and during hyperinsulinemia-hyperaminoacidemia in middle-aged adults. J Appl Physiol (1985). 2009 Oct;107(4):1308-15. doi: 10.1152/japplphysiol.00348.2009. Epub 2009 Jul 30.
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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.
Bettina Mittendorfer, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acids and corn oil in people with Healthy, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 5 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 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Evaluate the effect of omega-3 fatty acid supplementation on skeletal muscle protein synthesis rates both in the basal, postabsorptive state and in response to infusion of insulin and amino acids in young and older adults (time frame: Measurements taken prior to and following 8 weeks of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794079, which also lists 3 linked publications.
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 3 Aug 2011.