Minimum Time Effect of Fish Oil on Arterial Stiffness

NCT06981364 | Completed DMC

• 1 other identifier: 9
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Arterial Stiffness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Study Arms (2)

Fish Oil

EXPERIMENTAL

Participants randomized to fish oil will receive 4 grams of fish oil supplementation each day for the entire 6-week duration.

Dietary Supplement: Fish Oil

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Fish Oil

Interventions

Fish Oil DIETARY_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.

Fish Oil; Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Recent surgery
• Alcohol abusec
• Women must not be pregnant, plan to become pregnant during the study, or be nursing
• Claustrophobia

Sponsors & Collaborators

• Salisbury University: lead

Study Sites (1)

Salisbury University

Salisbury, Maryland, 21801, United States

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 20, 2025
• Study Start: October 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 5, 2023
• Last Updated: May 20, 2025

Record last verified: 2023-04

Locations

US (1)