Impact of Fish Oil Dose on Tissue Content and Function

NCT04772040 | Completed

• 1 other identifier: 280280
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

In this 5-month study, we will track the incorporation and washout of n-3 PUFA into different tissues following two different dosing strategies in healthy young and older volunteers. All groups will be followed for washout. Data gathered from this study will be used to establish novel dosing strategies and provide insights into the incorporation of n-3 PUFAs in different tissues and their washout in young and older participants.

Conditions

Aging; Sarcopenia; Muscle Atrophy

Keywords

Omega-3 polyunsaturated fatty acids; Fish oil supplementation; Washout; Dosing strategy

Outcome Measures

Primary Outcomes (3)

• Red blood cell lipid composition

  Changes in red blood cell membrane lipid composition by collecting venous blood samples.

  Screening, Baseline (0 weeks), 4 weeks, 6 weeks, 8 weeks, 12 weeks (post intervention), 14 weeks, 16 weeks, 20 weeks (post wash-out)

• Skeletal muscle lipid composition

  Changes in skeletal muscle lipid composition by performing a muscle tissue biopsy in the vastus lateralis.

  Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)

• Adipose tissue lipid composition

  Changes in adipose lipid composition by performing an adipose tissue biopsy in the abdominal region.

  Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)

Secondary Outcomes (3)

• Skeletal muscle tissue biopsy muscle protein turnover markers

  Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)

• Adipose tissue biopsy inflammation markers

  Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)

• Red blood cell lipid mediator markers

  Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)

Other Outcomes (4)

• Body composition DEXA scan.

  Baseline (0 weeks), 12 weeks (post-intervention), 20 weeks (post wash-out)

• Subcutaneous fat determination.

  Baseline (0 weeks), 12 weeks (post-intervention), 20 weeks (post wash-out)

• Strength measures

  Screening (baseline, 0 weeks), 8 weeks, 16 weeks.

Study Arms (4)

Young loading dose group

EXPERIMENTAL

Participants (18-35) will receive a loading dose of fish oil supplementation during the first 4 weeks of the intervention period of the study. In the last 8 weeks participants will receive a maintenance dose of fish oil supplementation. The total amount of EPA/DHA received throughout the supplementation period will be the same as the old group.

Dietary Supplement: Fish oil supplementation

Old loading dose group

EXPERIMENTAL

Participants (60y+) will receive a loading dose of fish oil supplementation during the first 4 weeks of the intervention period of the study. In the last 8 weeks participants will receive a maintenance dose of fish oil supplementation. The total amount of EPA/DHA received throughout the supplementation period will be the same as the young group.

Dietary Supplement: Fish oil supplementation

Young constant dose group

EXPERIMENTAL

Participants (18-35y) will receive a constant dose of fish oil supplementation throughout the intervention period of the study. Total amount of EPA/DHA received throughout the 12 weeks supplementation period will be the same as the loading groups.

Dietary Supplement: Fish oil supplementation

Old constant dose group

EXPERIMENTAL

Participants (60y+) will receive a constant dose of fish oil supplementation throughout the intervention period of the study. Total amount of EPA/DHA received throughout the 12 weeks supplementation period will be the same as the loading groups.

Dietary Supplement: Fish oil supplementation

Interventions

Fish oil supplementation DIETARY_SUPPLEMENT

Fish oil capsules.

Old constant dose group; Old loading dose group; Young constant dose group; Young loading dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide valid informed consent prior to any study procedure
• Males and females 18-35 years of age or 60+ years of age
• BMI between 18-29 kg/m2
• Free of musculoskeletal injuries
• Willing to avoid alcohol in the 48-h period prior to the visits
• Willing to sustain their current diet and lifestyle and not to make conscious changes for the duration of the study
• An omega-3 status of less than 20% seen in whole blood taken during the screening visit.
• Willing to sustain current use of supplementation/anti-depressants or other medication not interfering with the study results.
• Women: not currently pregnant, not intending to become pregnant in the coming 5 months or lactating.
• Women: willing to maintain current use of contraceptives or post-menopausal supplementation if any for the duration of the study.
• Not allergic to fish, shellfish, seaweed, iodine, anesthetics, nickel or chrome.

You may not qualify if:

• Smoker
• Adherence to a strict vegan/vegetarian diet
• Treatment for cardiovascular diseases or blood pressure \>140/90 mmHg
• Any diseases or medication that cause fat malabsorption (intestine issues such as celiac disease, Crohn's disease,chronic pancreatitis, or cystic fibrosis; liver and biliary disease, diarrhoea, steatorrhea)
• Diabetes or other (metabolic) disease that induce muscle wasting
• Surgery in prior 6 months
• Currently being on FO supplementation
• Current participation in another clinical trial, or in a trial within the past month
• For women: pregnant, intention to get pregnant during the course of the study or lactating

Sponsors & Collaborators

• University of Stirling: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

University of Stirling

Stirling, Stirlingshire, FK9 4LA, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Milena Banic, Msc

  University of Stirling

  PRINCIPAL INVESTIGATOR

• Nidia Rodriguez-Sanchez, PhD

  University of Stirling

  STUDY DIRECTOR

• Stuart Galloway, PhD

  University of Stirling

  STUDY DIRECTOR

• Oliver Witard, PhD

  King's College London

  STUDY DIRECTOR

• Miriam van Dijk-Ottens, PhD

  Danone Nutricia Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher

Model Details: Randomized controlled trial, parallel design.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: February 26, 2021
• Study Start: November 1, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)