Fat-free MasssNCT04245332
Effects of Fish Oil and Resistance Training on Muscle Mass and Function
A study testing Fish oil and Coconut oil in people with Fat-free Masss and Muscle Strength, run by Rowan University at 1 site in United States.
Trial summary
This study consists of a free-living, 6-week fish oil (FO) or placebo (PLA) supplementation intervention alongside participants' habitual resistance exercise training (RET) regimens. Twenty young, healthy resistance-trained subjects who do not currently supplement with FO will be recruited to participate. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat-free Masss, Muscle Strength, Neuromuscular Function
- What is being tested?
- Fish oil and Coconut oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 30 Sep 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young, healthy, resistance-trained men and women of all nationalities between the ages of 18-35
Who cannot join
- metabolic disease (diabetes or metabolic syndrome)
- cardiovascular disease
- pulmonary disease
- chronic inflammatory conditions (e.g. renal/kidney, liver, asthma, arthritis, autoimmune diseases, inflammatory bowel disease)
- neurological conditions (e.g. Parkinson's)
- sexually transmitted diseases
Show all 16Show fewer
- cancer diagnosis within the previous 5 years
- currently smoking cigarettes
- hypertension
- hypercholesterolemia and/or dyslipidemia
- using medications to manage cholesterol, blood lipids, blood pressure, or diabetes
- taking performance-enhancing drugs and/or anabolic agents (e.g. testosterone, growth hormone, or beta-2 agonists)
- oral contraceptive use, are pregnant, or intend to become pregnant while enrolled in the study
- fish oil supplement use within the past 6 months
- fasting blood total cholesterol concentration >200mg/dl
- fasting blood glucose concentration >100mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fish Oil Supplementation in Combination With Resistance Exercise Training on Body Composition, Strength and Neuromuscular Function in Young, Resistance-Trained Individuals: A Randomized, Open-Label, Placebo-Controlled Trial
This study consists of a free-living, 6-week fish oil (FO) or placebo (PLA) supplementation intervention alongside participants' habitual resistance exercise training (RET) regimens. Twenty young, healthy resistance-trained subjects who do not currently supplement with FO will be recruited to participate. An eligible participant will be between ages 18 and 35 and will have a minimum of two years of RET experience. Participants will be randomized into a FO group and a PLA group. The FO group will supplement with 4g/day of FO (4g fish oil concentrate: 2g EPA+ 1g DHA) and the PLA group will consume 4g/day of coconut oil (saturated fatty acids), as administered via gel capsules, in conjunction with their current RET program. Prior to intervention all participants will complete baseline biometric, strength, and neuromuscular testing. Participants will also have blood drawn to test for omega-3 fatty acid status, and complete and return a 3-day diet record and a physical activity recall. In order to monitor adherence to supplementation, FO and PLA bottles will also be returned weekly and pills will be counted. 3-day diet records will be obtained to ensure calorie and protein intakes remain consistent throughout the intervention period. Weekly physical activity records will also help to ensure consistency of participant training and to make sure all participants are following their training regimes in a progressive fashion. Following 6 weeks of FO or PLA supplementation, subjects will repeat all initial biometric, strength and neuromuscular testing, as well as a second, post-intervention blood draw.
Read the detailed description
Potential participants will report to the Human Performance Lab (HPL) in James Hall to complete the screening process. They will complete the informed consent form process with a member of the research team before providing any protected health information (PHI). The screening process has two components: questionnaires and physical measures. Potential participants will complete the following questionnaires: Stanford 7-Day Physical Activity Questionnaire and a Medical History Questionnaire. Participants will complete the following physical measures: height, weight, waist and hip circumference, and blood pressure will be assessed and followed by calculations of body mass index (BMI) and waist to hip ratio (WHR). The final measure will be a determination of fasting total cholesterol and blood glucose measured via capillary blood from a finger prick using an automated analyzer. The purpose of the screening process is to determine if a participant is healthy and can safely participate in exercise testing, and to determine their eligibility to participate in the study based on the criteria listed elsewhere.
Participants who meet the eligibility criteria and are willing to participate will be enrolled in the study and randomly assigned to FO or PLA via block randomization methods. Enrolled participants will return to the HPL in the morning to complete a battery of biometric tests (described below) and will be given two logs to complete to collect baseline data: the Stanford 7-Day Physical Activity Questionnaire and a 3-day diet log. The purpose of the physical activity log is to determine their average level of physical activity and training program. The purpose of the 3-day diet log is to record their normal dietary intake and to provide practice for completing these logs as they will be completed on a weekly basis during the supplement intervention period.
Participants will have the following physical measures recorded: height, weight, waist and hip circumference, body composition, and blood pressure. Participants will then have their resting metabolic rate (RMR) measured by indirect calorimetry. In preparation for this test participants will be asked to complete an overnight fast of at least 9 hours, abstain from caffeine for 12 hours and abstain from exercise and alcohol for 24 hours. Participants will be brought to a quiet room and asked to lie in a supine position for 30 minutes of rest. They will then be fitted with a breathing mask connected to the metabolic cart and their breath will be analyzed for 15 minutes while they continue to lie in a supine position. Their total energy expenditure will be calculated using their RMR and a physical activity factor based on their level of physical activity obtained from the Stanford 7-Day Physical Activity Questionnaire. Subject's total daily calorie requirements will then be verified using their 3-day diet record and the Mifflin-St. Jeor prediction equation. In order to ensure that participants are consuming enough calories in order to maintain their body weight during the 6-week supplementation period, the research team will use the average of participant's total calorimetric data (based on RMR), 3-day diet log, and the Mifflin-St. Jeor estimate.
Participants will be sent pre-participation instructions before testing to ensure they arrive at the HPL with proper exercise attire and having abstained from caffeine for 12 hours and exercise and alcohol for 24 hours. They will report to the HPL to complete a 1RM test, a type of muscular strength assessment. This test will be performed for the back squat in a Smith machine with hand release breaks. Water will be provided and consumed ad libitum. Bench press and Squat will be completed with proper lifting technique as described by the National Strength and Conditioning Association (NSCA) guidelines.
Participants' lower body neuromuscular function, assessed via maximal voluntary contraction (MVC) and rate of force development (RFD), will be completed through the use of force transducers applied to the legs. Participants will be seated in a custom-made wooden box with a single axis transducer attached to one of its surfaces (SM-500, Interface Inc., Scottsdale, Arizona, USA). When subjects sit on the box, their knee and hip joints will be at approximately 70° and 90° of flexion from full extension, respectively. Subjects will be asked to cross their arms across their chest during the testing.
Dietary compliance will be monitored weekly during the free-living supplementation period using 3-day diet records and returned supplement pill bottles. 3-day diet records will be recorded by the participants and returned to the research team for analysis using professional nutrition analysis software (Food Processor, Oregon). Dietary analysis results will be discussed with the participant in order to help them adhere to dietary recommendations. Body weight measures will be recorded once per week to ensure a stable weight during the dietary intervention period. The participants will return supplement bottles weekly, and the research team will count and record any remaining capsules. Finally, physical activity logs will be collected every week to ensure diet and calorie recommendations are meeting the demands of RET.
- Conditions
- Fat-free Masss, Muscle Strength, Neuromuscular Function
- Being tested
- Fish oil, Coconut oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Also called NOW Foods Ultra Omega-3
Fish oil-derived omega-3 polyunsaturated fatty acids (4g fish oil concentrate: 2g EPA+ 1g DHA)
Coconut oilDietary supplement
Also called NOW Foods Virgin Coconut Oil Softgels
Coconut oil (4g/d)
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | This group will receive fish oil (4g/d). Receives: Dietary Supplement: Fish oil |
| Placebo | Placebo comparator | This group will receive coconut oil (4g/d) as an iso-energetic, iso-lipidic placebo comparator to the fish oil arm. Receives: Dietary Supplement: Coconut oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat-free mass (FFM)
Measured by bioelectrical impedance analysis (BIA)
Measured: 6 weeks
Muscle strength
Measured by one-repetition maximal (1RM) strength in back squat, bench press, and knee extensor
Measured: 6 weeks
Rate of force development (RFD)
Assessed by force transducers on legs and in hands
Measured: 6 weeks
Maximal voluntary contraction (MVC)
Assessed by force transducers on legs and in hands
Measured: 6 weeks
Secondary outcomes (1)
Red blood cell omega-3 fatty acid concentrations (Eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA])
Assessed by gas chromatography-mass spectrometry (GS-MS)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start29 Jan 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: COVID-19 restrictions on research at University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat-free MasssStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dylan Klein, Ph.D., Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245332
- Sponsor's protocol ID
- Pro2019000649
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2020
- Last updated
- 10 Mar 2021
- Results posted
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fish Oil Supplementation in Combination With Resistance Exercise Training on Body Composition, Strength and Neuromuscular Function in Young, Resistance-Trained Individuals: A Randomized, Open-Label, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04245332
- Acronym / sponsor ID
- Pro2019000649
- Conditions
- Fat-free Masss, Muscle Strength, Neuromuscular Function
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 restrictions on research at University
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 28 Jan 2020 (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.
This study consists of a free-living, 6-week fish oil (FO) or placebo (PLA) supplementation intervention alongside participants' habitual resistance exercise training (RET) regimens. Twenty young, healthy resistance-trained subjects who do not currently supplement with FO will be recruited to participate. An eligible participant will be between ages 18 and 35 and will have a minimum of two years of RET experience. Participants will be randomized into a FO group and a PLA group. The FO group will supplement with 4g/day of FO (4g fish oil concentrate: 2g EPA+ 1g DHA) and the PLA group will consume 4g/day of coconut oil (saturated fatty acids), as administered via gel capsules, in conjunction with their current RET program. Prior to intervention all participants will complete baseline biometric, strength, and neuromuscular testing. Participants will also have blood drawn to test for omega-3 fatty acid status, and complete and return a 3-day diet record and a physical activity recall. In order to monitor adherence to supplementation, FO and PLA bottles will also be returned weekly and pills will be counted. 3-day diet records will be obtained to ensure calorie and protein intakes remain consistent throughout the intervention period. Weekly physical activity records will also help to ensure consistency of participant training and to make sure all participants are following their training regimes in a progressive fashion. Following 6 weeks of FO or PLA supplementation, subjects will repeat all initial biometric, strength and neuromuscular testing, as well as a second, post-intervention blood draw.
Detailed description
Potential participants will report to the Human Performance Lab (HPL) in James Hall to complete the screening process. They will complete the informed consent form process with a member of the research team before providing any protected health information (PHI). The screening process has two components: questionnaires and physical measures. Potential participants will complete the following questionnaires: Stanford 7-Day Physical Activity Questionnaire and a Medical History Questionnaire. Participants will complete the following physical measures: height, weight, waist and hip circumference, and blood pressure will be assessed and followed by calculations of body mass index (BMI) and waist to hip ratio (WHR). The final measure will be a determination of fasting total cholesterol and blood glucose measured via capillary blood from a finger prick using an automated analyzer. The purpose of the screening process is to determine if a participant is healthy and can safely participate in exercise testing, and to determine their eligibility to participate in the study based on the criteria listed elsewhere.
Participants who meet the eligibility criteria and are willing to participate will be enrolled in the study and randomly assigned to FO or PLA via block randomization methods. Enrolled participants will return to the HPL in the morning to complete a battery of biometric tests (described below) and will be given two logs to complete to collect baseline data: the Stanford 7-Day Physical Activity Questionnaire and a 3-day diet log. The purpose of the physical activity log is to determine their average level of physical activity and training program. The purpose of the 3-day diet log is to record their normal dietary intake and to provide practice for completing these logs as they will be completed on a weekly basis during the supplement intervention period.
Participants will have the following physical measures recorded: height, weight, waist and hip circumference, body composition, and blood pressure. Participants will then have their resting metabolic rate (RMR) measured by indirect calorimetry. In preparation for this test participants will be asked to complete an overnight fast of at least 9 hours, abstain from caffeine for 12 hours and abstain from exercise and alcohol for 24 hours. Participants will be brought to a quiet room and asked to lie in a supine position for 30 minutes of rest. They will then be fitted with a breathing mask connected to the metabolic cart and their breath will be analyzed for 15 minutes while they continue to lie in a supine position. Their total energy expenditure will be calculated using their RMR and a physical activity factor based on their level of physical activity obtained from the Stanford 7-Day Physical Activity Questionnaire. Subject's total daily calorie requirements will then be verified using their 3-day diet record and the Mifflin-St. Jeor prediction equation. In order to ensure that participants are consuming enough calories in order to maintain their body weight during the 6-week supplementation period, the research team will use the average of participant's total calorimetric data (based on RMR), 3-day diet log, and the Mifflin-St. Jeor estimate.
Participants will be sent pre-participation instructions before testing to ensure they arrive at the HPL with proper exercise attire and having abstained from caffeine for 12 hours and exercise and alcohol for 24 hours. They will report to the HPL to complete a 1RM test, a type of muscular strength assessment. This test will be performed for the back squat in a Smith machine with hand release breaks. Water will be provided and consumed ad libitum. Bench press and Squat will be completed with proper lifting technique as described by the National Strength and Conditioning Association (NSCA) guidelines.
Participants' lower body neuromuscular function, assessed via maximal voluntary contraction (MVC) and rate of force development (RFD), will be completed through the use of force transducers applied to the legs. Participants will be seated in a custom-made wooden box with a single axis transducer attached to one of its surfaces (SM-500, Interface Inc., Scottsdale, Arizona, USA). When subjects sit on the box, their knee and hip joints will be at approximately 70° and 90° of flexion from full extension, respectively. Subjects will be asked to cross their arms across their chest during the testing.
Dietary compliance will be monitored weekly during the free-living supplementation period using 3-day diet records and returned supplement pill bottles. 3-day diet records will be recorded by the participants and returned to the research team for analysis using professional nutrition analysis software (Food Processor, Oregon). Dietary analysis results will be discussed with the participant in order to help them adhere to dietary recommendations. Body weight measures will be recorded once per week to ensure a stable weight during the dietary intervention period. The participants will return supplement bottles weekly, and the research team will count and record any remaining capsules. Finally, physical activity logs will be collected every week to ensure diet and calorie recommendations are meeting the demands of RET.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish oilThis group will receive fish oil (4g/d). |
| Placebo | Placebo comparator | Dietary Supplement: Coconut oilThis group will receive coconut oil (4g/d) as an iso-energetic, iso-lipidic placebo comparator to the fish oil arm. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young, healthy, resistance-trained men and women of all nationalities between the ages of 18-35
Key exclusion criteria (16 listed)
- metabolic disease (diabetes or metabolic syndrome)
- cardiovascular disease
- pulmonary disease
- chronic inflammatory conditions (e.g. renal/kidney, liver, asthma, arthritis, autoimmune diseases, inflammatory bowel disease)
- neurological conditions (e.g. Parkinson's)
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 |
|---|---|---|
| Fish oilAlso: NOW Foods Ultra Omega-3Fish oil-derived omega-3 polyunsaturated fatty acids (4g fish oil concentrate: 2g EPA+ 1g DHA) | Dietary supplement | Fish Oil |
| Coconut oilAlso: NOW Foods Virgin Coconut Oil SoftgelsCoconut oil (4g/d) | Dietary supplement | Placebo |
Primary outcome
Total body fat-free mass (FFM)
Time frame: 6 weeks
Measured by bioelectrical impedance analysis (BIA)
Muscle strength
Time frame: 6 weeks
Measured by one-repetition maximal (1RM) strength in back squat, bench press, and knee extensor
Rate of force development (RFD)
Time frame: 6 weeks
Assessed by force transducers on legs and in hands
Maximal voluntary contraction (MVC)
Time frame: 6 weeks
Assessed by force transducers on legs and in hands
1 secondary outcome
Red blood cell omega-3 fatty acid concentrations (Eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA])
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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.
Dylan Klein, Ph.D. principal investigator
Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil and Coconut oil in people with Fat-free Masss and Muscle Strength, run by Rowan University 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 1 inclusion and 16 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: paused, as of the sponsor's last update on 10 Mar 2021. 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?
Results are not available in the source record.
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?
Total body fat-free mass (FFM) (time frame: 6 weeks). The study lists 4 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 10 Mar 2021.