Arterial StiffnessNCT06981364
Minimum Time Effect of Fish Oil on Arterial Stiffness
A study testing Fish Oil in people with Arterial Stiffness, run by Salisbury University at 1 site in United States.
Trial summary
This study will seek to determine the minimum time of 4 g/day fish oil supplementation to cause a clinically significant effect on arterial stiffness. Accordingly, 30 moderately active, otherwise healthy adult subjects who are not currently taking any dietary supplementations will be recruited for the study. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- Fish Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 5 Jan 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30 yearsa,d
- Moderately active (exercise 3-5 days per week, >30 min per day)
- Weight stable for previous 6 months (>2.5 kg)
- Willing to be randomized to treatments and commit to all aspect of study
- Provide health history questionnaire and informed consent.
- Female subjects only- reported regular menstrual cycles for the last 2 years
Who cannot join
- BP>140/90
- Diabetes
- Familial hypercholesterolemia
- Past or current history of CHD, stroke or major CVD events. Respiratory diseases, endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
- Active renal or liver disease
- All medications that influence dependent variablesb
Show all 10Show fewer
- Recent surgery
- Alcohol abusec
- Women must not be pregnant, plan to become pregnant during the study, or be nursing
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
This study will seek to determine the minimum time of 4 g/day fish oil supplementation to cause a clinically significant effect on arterial stiffness. Accordingly, 30 moderately active, otherwise healthy adult subjects who are not currently taking any dietary supplementations will be recruited for the study. They will be randomized in a double-blind fashion into one of two groups: placebo group or fish oil dietary supplementation group. Subjects will either receive 4 g/day fish oil or placebo for 6 weeks. Each subject will undergo a series of baseline and follow-up tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, and blood pressure acquisition at week 0, 2, 4, and 6. Subjects will be required to maintain an activity and food log. Subjects will be asked to maintain their normal activity pattern during the study period. Repeated measures analysis of variance will be used to examine the effects of treatment and the treatment-order interaction on arterial stiffness (and other dependent variables).
Read the detailed description
To determine the minimum amount of time for a clinically significant effect of daily fish oil supplementation on arterial stiffness (Figure 1). 30 subjects will be randomized in a double-blind fashion into one of two groups: placebo group or fish oil dietary supplementation group. An individual not associated with the project will monitor the randomization and blinding process. He/she will not be involved in the follow-up data collection. All analyses will be conducted in a blinded fashion.
Pre-enrollment Screening. Several study information sessions will be offered to potential subjects prior to the start of the study. These information sessions will be conducted by the principle investigator. The principle investigator will also arrange office meetings for those who have a time conflict with the information sessions. After obtaining written informed consent the potential candidates will be screened to determine if they satisfy the basic criteria of the study (see below). Candidates will be instructed to fill out a Health History Questionnaire in a place of their choosing. Candidates who successfully complete the screening process will be invited to undergo baseline and follow-up testing (see details below).
Baseline and Follow-up Testing: For baseline and follow-up testing subjects will arrive at Salisbury University Simulation Center between 8:00 and 11:00 am after a 12 hour overnight fast and having performed no vigorous physical activity for the previous 48 hours. Subjects will also be required to abstain from caffeine-containing food or beverages for the previous 24 hours. Each visit will be separated by a period of two weeks.
Visit 1: Resting BP; urine sample (female participants only); anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Visit 2: Resting BP; anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Visit 3: Resting BP; anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Visit 4: Resting BP; anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Note #1: If resting BP measurements are >130/80 mmHg during the first visit, the subject will be asked to schedule the session at least 48 hours later. If the resting BP measurements are >130/80 mmHg during the next visit, they will be excluded from the study and instructed to follow-up with their primary care provider.
- Conditions
- Arterial Stiffness
- Being tested
- Fish Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Upon completion of baseline testing both groups will be instructed not to alter their normal diet and activity levels throughout the study period. Zach Townsend, an individual who will not be directly involved with the data analysis, will create a spread sheet containing the weight of the subjects and separate identifier generated via algorithm. The spread sheet will be provided to the principle and co-investigators who will partition the supplements out into 42 separate sealable bags per subject. The bags will be dispersed by Mr. Townsend to maintain the double-blind standard. Subjects will either consume 4 g/day GNC Triple Strength Fish Oil Mini, General Nutrition Corporation, Pittsburgh, PA, or placebo (dextrin) of equal volume for six weeks. They will be instructed to consume fish oil or the placebo with a glass of water at the same time every day. These protocols are similar to ones used in previous investigations1-7.
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | Participants randomized to fish oil will receive 4 grams of fish oil supplementation each day for the entire 6-week duration. Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Aim
The primary outcome of the proposed study will be beta-stiffness which is calculated from maximal and minimal carotid diameters and carotid systolic and diastolic pressures.
Measured: 6 weeks
Primary Aim
The secondary outcome of the proposed study will be pulse wave velocity which is measure of the time delay between the arrival of the pulse wave at the carotid and femoral arteries.
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 posted20 May 2025
- Study start1 Oct 2022
- Primary completion15 Dec 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salisbury University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981364
- Sponsor's protocol ID
- 9
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Time Effect of Fish Oil on Arterial Stiffness
- ClinicalTrials.gov ID
- NCT06981364
- Acronym / sponsor ID
- 9
- Conditions
- Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Salisbury UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 20 May 2025 (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 will seek to determine the minimum time of 4 g/day fish oil supplementation to cause a clinically significant effect on arterial stiffness. Accordingly, 30 moderately active, otherwise healthy adult subjects who are not currently taking any dietary supplementations will be recruited for the study. They will be randomized in a double-blind fashion into one of two groups: placebo group or fish oil dietary supplementation group. Subjects will either receive 4 g/day fish oil or placebo for 6 weeks. Each subject will undergo a series of baseline and follow-up tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, and blood pressure acquisition at week 0, 2, 4, and 6. Subjects will be required to maintain an activity and food log. Subjects will be asked to maintain their normal activity pattern during the study period. Repeated measures analysis of variance will be used to examine the effects of treatment and the treatment-order interaction on arterial stiffness (and other dependent variables).
Detailed description
To determine the minimum amount of time for a clinically significant effect of daily fish oil supplementation on arterial stiffness (Figure 1). 30 subjects will be randomized in a double-blind fashion into one of two groups: placebo group or fish oil dietary supplementation group. An individual not associated with the project will monitor the randomization and blinding process. He/she will not be involved in the follow-up data collection. All analyses will be conducted in a blinded fashion.
Pre-enrollment Screening. Several study information sessions will be offered to potential subjects prior to the start of the study. These information sessions will be conducted by the principle investigator. The principle investigator will also arrange office meetings for those who have a time conflict with the information sessions. After obtaining written informed consent the potential candidates will be screened to determine if they satisfy the basic criteria of the study (see below). Candidates will be instructed to fill out a Health History Questionnaire in a place of their choosing. Candidates who successfully complete the screening process will be invited to undergo baseline and follow-up testing (see details below).
Baseline and Follow-up Testing: For baseline and follow-up testing subjects will arrive at Salisbury University Simulation Center between 8:00 and 11:00 am after a 12 hour overnight fast and having performed no vigorous physical activity for the previous 48 hours. Subjects will also be required to abstain from caffeine-containing food or beverages for the previous 24 hours. Each visit will be separated by a period of two weeks.
Visit 1: Resting BP; urine sample (female participants only); anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Visit 2: Resting BP; anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Visit 3: Resting BP; anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Visit 4: Resting BP; anthropometric measurements; high resolution ultrasound and carotid tonometry for measurement of arterial stiffness; pulse wave velocity; dispensing of placebo or fish oil supplement.
Note #1: If resting BP measurements are >130/80 mmHg during the first visit, the subject will be asked to schedule the session at least 48 hours later. If the resting BP measurements are >130/80 mmHg during the next visit, they will be excluded from the study and instructed to follow-up with their primary care provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish OilParticipants randomized to fish oil will receive 4 grams of fish oil supplementation each day for the entire 6-week duration. |
| Placebo | Placebo comparator | Dietary Supplement: Fish OilPlacebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-30 yearsa,d
- Moderately active (exercise 3-5 days per week, >30 min per day)
- Weight stable for previous 6 months (>2.5 kg)
- Willing to be randomized to treatments and commit to all aspect of study
- Provide health history questionnaire and informed consent.
Key exclusion criteria (10 listed)
- BP>140/90
- Diabetes
- Familial hypercholesterolemia
- Past or current history of CHD, stroke or major CVD events. Respiratory diseases, endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
- Active renal or liver disease
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 OilUpon completion of baseline testing both groups will be instructed not to alter their normal diet and activity levels throughout the study period. Zach Townsend, an individual who will not be directly involved with the data analysis, will create a spread sheet containing the weight of the subjects and separate identifier generated via algorithm. The spread sheet will be provided to the principle and co-investigators who will partition the supplements out into 42 separate sealable bags per subject. The bags will be dispersed by Mr. Townsend to maintain the double-blind standard. Subjects will either consume 4 g/day GNC Triple Strength Fish Oil Mini, General Nutrition Corporation, Pittsburgh, PA, or placebo (dextrin) of equal volume for six weeks. They will be instructed to consume fish oil or the placebo with a glass of water at the same time every day. These protocols are similar to ones used in previous investigations1-7. | Dietary supplement | Fish Oil, Placebo |
Primary outcome
Primary Aim
Time frame: 6 weeks
The primary outcome of the proposed study will be beta-stiffness which is calculated from maximal and minimal carotid diameters and carotid systolic and diastolic pressures.
Primary Aim
Time frame: 6 weeks
The secondary outcome of the proposed study will be pulse wave velocity which is measure of the time delay between the arrival of the pulse wave at the carotid and femoral arteries.
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 20 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Arterial Stiffness, run by Salisbury 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 6 inclusion and 10 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 20 May 2025. 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?
Primary Aim (time frame: 6 weeks). 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 20 May 2025.