NCT04279951

Brief Summary

The study aims to investigate the effects of double-blinded, randomized placebo-controlled n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of resistance training on muscle function/biology and systemic health in individuals with obesity (BMI\>30) and lean individuals (BMI\<30)

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
7mo left

Started Sep 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2019Dec 2026

Study Start

First participant enrolled

September 2, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

January 19, 2020

Last Update Submit

August 8, 2022

Conditions

Obesity

Keywords

Resistance exerciseOmega 3

Outcome Measures

Primary Outcomes (2)

  • Muscle thickness, ultrasound

    Muscle thickness of vastus lateralis and vastus intermedius measured using ultrasound

    Changes from before to after the resistance training intervention (week 8 to 20)

  • Glucose tolerance

    Glucose tolerance measured using an oral glucose tolerance test

    Changes from before to after the resistance training intervention (week 8 to 20)

Secondary Outcomes (48)

  • Lean body mass

    Changes from before to after the resistance training intervention (week 8 to 20)

  • Fat mass

    Changes from before to after the resistance training intervention (week 8 to 20)

  • Visceral fat mass

    Changes from before to after the resistance training intervention (week 8 to 20)

  • Muscle mass, MRI

    Changes from before to after the resistance training intervention (week 8 to 20)

  • Muscle mass, immunohistochemistry

    Changes from before to after the resistance training intervention (week 8 to 20)

  • +43 more secondary outcomes

Other Outcomes (2)

  • Training diary relating to the intervention protocol

    Weeks 8 to 20

  • Dietary registration

    Week 0, 8 and 20

Study Arms (3)

Omega 3

EXPERIMENTAL

Intake of 1 gram omega-3 (capsules) per day for 20 weeks \+ high-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training)

Other: Resistance exerciseDietary Supplement: Omega-3

Placebo

PLACEBO COMPARATOR

Intake of 1 gram sunflower oleic oil (capsules) per day for 20 weeks \+ high-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training)

Other: Resistance exerciseDietary Supplement: Placebo

Control

NO INTERVENTION

No intervention

Interventions

Resistance exerciseOTHER

High-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training)

Omega 3Placebo
Omega-3DIETARY_SUPPLEMENT

1 gram of omega-3 per day for 20 weeks

Also known as: N-3 PUFA
Omega 3
PlaceboDIETARY_SUPPLEMENT

1 gram of sunflower oleic oil per day for 20 weeks

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Untrained (less than 2 sessions of resistance exercise per month and less than 3 hours of endurance exercise per week)

You may not qualify if:

  • Unstable cardiovascular disease
  • Injuries affecting the ability to perform heavy resistance exercise
  • Mental illness
  • Allergy to local anesthesia
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inland Norway University of Applied Sciences

Lillehammer, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Resistance TrainingDocosahexaenoic AcidsFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Stian Ellefsen, PhD

    Inland Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2020

First Posted

February 21, 2020

Study Start

September 2, 2019

Primary Completion

March 30, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

NO(1)