Minimum Time Effect of Fish Oil on Arterial Stiffness

NCT06981364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-05-20

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Fish Oil

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.

Sponsors & Collaborators

  • Salisbury University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2022-12-15
Completion
2023-01-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981364 on ClinicalTrials.gov