NCT04245332

Brief 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. 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 29, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

January 27, 2020

Last Update Submit

March 8, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Total body fat-free mass (FFM)

    Measured by bioelectrical impedance analysis (BIA)

    6 weeks

  • Muscle strength

    Measured by one-repetition maximal (1RM) strength in back squat, bench press, and knee extensor

    6 weeks

  • Rate of force development (RFD)

    Assessed by force transducers on legs and in hands

    6 weeks

  • Maximal voluntary contraction (MVC)

    Assessed by force transducers on legs and in hands

    6 weeks

Secondary Outcomes (1)

  • Red blood cell omega-3 fatty acid concentrations (Eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA])

    6 weeks

Study Arms (2)

Fish Oil

EXPERIMENTAL

This group will receive fish oil (4g/d).

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.

Dietary Supplement: Coconut oil

Interventions

Fish oilDIETARY_SUPPLEMENT

Fish oil-derived omega-3 polyunsaturated fatty acids (4g fish oil concentrate: 2g EPA+ 1g DHA)

Also known as: NOW Foods Ultra Omega-3
Fish Oil
Coconut oilDIETARY_SUPPLEMENT

Coconut oil (4g/d)

Also known as: NOW Foods Virgin Coconut Oil Softgels
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young, healthy, resistance-trained men and women of all nationalities between the ages of 18-35

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University

Glassboro, New Jersey, 08028, United States

Location

MeSH Terms

Interventions

Fish OilsCoconut Oil

Intervention Hierarchy (Ancestors)

OilsLipidsDietary FatsFatsPlant Oils

Study Officials

  • Dylan Klein, Ph.D.

    Rowan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 28, 2020

Study Start

January 29, 2020

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations