ISRCTN ISRCTN11524409
DOI https://doi.org/10.1186/ISRCTN11524409
Secondary identifying numbers KrillOil002
Submission date
27/10/2017
Registration date
31/10/2017
Last edited
16/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Jacob Wilson
Scientific

5850 W Cypress Street
Tampa
33607
United States of America

Study information

Study designSingle-center randomised double-blind placebo-controlled parallel interventional study
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet No participant information sheet available.
Scientific titleThe effects of krill oil supplementation combined with resistance training on body composition and athletic performance
Study objectivesThe 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(s)IntegReview IRB, Austin, TX, 14/03/2016, ref: Protocol Number: 7952
Health condition(s) or problem(s) studiedHealthy volunteers
InterventionParticipants 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 typeSupplement
Primary outcome measure1. 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 measures1. 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 study start date01/01/2016
Completion date31/12/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants21
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment15/03/2016
Date of final enrolment01/11/2016

Locations

Countries of recruitment

  • United States of America

Study participating centre

Applied Science and Performance Institute
Tampa
33607
United States of America

Sponsor information

Rimfrost USA
Industry

841 Avoca Farm Road
Merry Hill
27957
United States of America

ROR logo "ROR" https://ror.org/02q6tz689

Funders

Funder type

Industry

Rimfrost USA

No information available

Results and Publications

Intention to publish date01/04/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jacob M Wilson, jwilson@theaspi.com.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/04/2018 Yes No

Editorial Notes

16/10/2018: Publication reference added.