NCT02338401

Brief Summary

Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy expenditure of tissues (Manini 2010). It has also been shown that as we age there is a:

  • Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and Gallagher 2010).
  • A change towards a more saturated membrane of different tissues (Rabini et al 2002). Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into cell membranes may alter energy metabolism by:
  • Increasing the rate at which proteins operate (Hulbert 2007).
  • Promoting the release of EPA and DHA into the cytosol which will act as ligands for peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an important role in energy homeostasis by regulating genes involved in lipid metabolism (Kota et al 2005).
  • Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo et al 2014). Supplementation with fish oil in older males and females:
  • Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).
  • Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)
  • Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM) accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to speculate that these changes may occur by some of the mechanisms described earlier, with skeletal muscle being an important contributor. To date there are no studies that have examined the effect of n-3 supplementation (3g/day)\* on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible mechanisms behind it. Therefore the purpose of this study is to determine whether in older adults (female and male), supplementation with n-3 alters:
  • RMR and fatty acid oxidation.
  • Membrane composition of whole muscle and sarcolemma.
  • Content of skeletal muscle membrane fatty acid transport proteins.
  • Dose response of NaKATPase and SERCA efficiency
  • Content of mitochondrial proteins
  • Expression and content of PPARs and proteins involved in translocation of FA transporters (AMPK, ERK1/2, CamKII).
  • Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).
  • Proteomic profile of skeletal muscle.
  • Body composition

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

January 10, 2015

Last Update Submit

May 1, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in skeletal muscle whole muscle membrane fatty acid composition from baseline

    Baseline and 12 weeks

  • Change in skeletal muscle sodium pump (Na/K ATPase) activity (umol/mg protein/hour)

    Baseline and 12 weeks

  • Change in skeletal muscle sarcoplasmic reticulum calcium (SERCA) ATPase activity (umol/mg protein/hour)

    Baseline and 12 weeks

Secondary Outcomes (6)

  • Change in whole body resting metabolic rate

    Baseline, 6 and 12 weeks

  • Change in skeletal muscle membrane fatty acid transporter content

    Baseline and 12 weeks

  • Change in skeletal muscle content of mitochondrial proteins

    Baseline and 12 weeks

  • Change in skeletal muscle phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286)

    Baseline and 12 weeks

  • Change in skeletal muscle PPARs content

    Baseline and 12 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Change in Whole Body Resting Fat Oxidation From Baseline

    Baseline, 6 and 12 weeks

  • Change in Whole Body Resting Carbohydrate Oxidation From Baseline

    Baseline, 6 and 12 weeks

  • Change in Fasted Blood Triglyceride Concentration From Baseline

    Baseline and 12 weeks

Study Arms (2)

Omega-3 Complete

EXPERIMENTAL

Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.

Dietary Supplement: Omega-3 Complete

Placebo Pill

PLACEBO COMPARATOR

Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.

Dietary Supplement: Placebo Pill

Interventions

Omega-3 CompleteDIETARY_SUPPLEMENT

Fish Oil Capsules

Omega-3 Complete
Placebo PillDIETARY_SUPPLEMENT

Olive Oil Capsules

Placebo Pill

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 60 and 75 years old
  • Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study

You may not qualify if:

  • Have any medical condition (no evidence of significant cardiovascular disease or organ dysfunction, including hypertension, dyslipidemia, and diabetes mellitus), and hospitalization or surgeries
  • Consume more than two meals of fish/wk and/or have taken an omega-3 supplement during the prior three months.
  • Have a BMI \> 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair Human Health and Nutritional Sciences

Study Record Dates

First Submitted

January 10, 2015

First Posted

January 14, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations