Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/10/2017
Date assigned
31/10/2017
Last edited
31/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Resistance training describes a type of training where you move against a force that resists your movement. Krill Oil is a supplement that could be helpful to those who are doing resistance training.
The aim of this study is to investigate the effect of a nutritional intervention, Krill Oil, in combination with resistance training on muscular health in healthy participants.

Who can participate?
Males aged 18 to 30 years old who are currently doing resistance training at least two times per week for the past six months.

What does the study involve?
Participants undergo a resistance training program (programmed, non-linear training split) four days per week for a period of 8 weeks. Participants are randomly allocated to one of two groups. Those in the first group receive 3grams of a placebo (a dummy capsule) that contains safflower oil. Those in the second group receive the Krill oil (3 grams) capsule. Supplements are consumed prior to workouts on training days while eating breakfast on non-training days. Participants are assessed for their body composition and muscle strength after eight weeks.

What are the possible benefits and risks of participating?
Participants may benefit from an increase in lean body mass and strength. Participation in exercise includes the potential risk of injury.

Where is the study run from?
Applied Science and Performance Institute (USA)

When is the study starting and how long is it expected to run for?
January 2016 to December 2016

Who is funding the study?
Rimfrost USA (USA)

Who is the main contact?
Dr Jacob Wilson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacob Wilson

ORCID ID

Contact details

5850 W Cypress Street
Tampa
33607
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KrillOil002

Study information

Scientific title

The effects of krill oil supplementation combined with resistance training on body composition and athletic performance

Acronym

Study hypothesis

The aim of this study is to investigate the ability of Krill Oil to augment resistance training-induced changes in body composition and performance.

Ethics approval

IntegReview IRB, Austin, TX, 14/03/2016, ref: Protocol Number: 7952

Study design

Single-center randomised double-blind placebo-controlled parallel interventional study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

No participant information sheet available.

Condition

Healthy volunteers

Intervention

Participants undergo a resistance training program (programmed, non-linear training split) four days per week for a period of 8 weeks.

Participants are allocated to one of two groups. Those in the first group receive 3 grams of Placebo (safflower oil) in a softgel 6500 mg capsule. Those in the second group receive 3 grams of Krill (Euphausia superba) Oil (Rimfrost Sublime, Rimfrost USA LLC, Merry Hill, NC, USA, Lot 8723-15-01-03), administered as 6 500mg softgel capsules.

Supplements are consumed pre-workout on training days, and with breakfast on non-training days.

Participants are followed up for their body composition using the whole-body Dual-Energy X-ray Absorptiometry (DXA) at baseline and 8 weeks. Participants are assessed for their strength using one repetition maximum (1RM) on a bench press and leg press at baseline and 8 weeks.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Body composition is measured using the whole-body Dual-Energy X-ray Absorptiometry (DXA) at baseline and 8 weeks
2. Strength is measured using one repetition maximum (1RM) on a bench press and leg press at baseline and 8 weeks

Secondary outcome measures

1. Perceptual Measures is measured using perceived recovery at beginning and end of every week
2. Cognition is measured using a Stroop Test at baseline and eight weeks
3. Safety is measured using comprehensive metabolic panel (CMP) at baseline and eight weeks
4. Complete blood count (CBC) and lipid panels is measured using blood tests at baseline and eight weeks

Overall trial start date

01/01/2016

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males 18 to 30 years of age
2. Resistance training at least 2 times per week for the past six months
3. Minimum of 1 year of training experience active
4. Currently resistance training

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

21

Participant exclusion criteria

1. Free of musculoskeletal, metabolic, and respiratory disorders
2. Free of cardiovascular disease
3. No musculoskeletal injuries with the last six months
4. No history of smoking or drug use
5. No history of excessive alcohol consumption
6. Not taking prescription medication
7. Have not used a fish oil-, thermogenic-, protein-, amino acid-, or creatine supplement within the prior two months
8. Have not habitually used caffeine (e.g. more than 2 cups of coffee per day)

Recruitment start date

15/03/2016

Recruitment end date

01/11/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

Applied Science and Performance Institute
Tampa
33607
United States of America

Sponsor information

Organisation

Rimfrost USA

Sponsor details

841 Avoca Farm Road
Merry Hill
27957
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Rimfrost USA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jacob M Wilson, jwilson@theaspi.com.

Intention to publish date

01/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes