Free-range reindeer consumption improves protein metabolism in humans

ISRCTN ISRCTN14872031
DOI https://doi.org/10.1186/ISRCTN14872031
Secondary identifying numbers IRBnet 749396
Submission date
24/04/2020
Registration date
07/05/2020
Last edited
05/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Alaska’s Indigenous people are growing in number, especially the elderly sector. These groups experience greater functional disabilities throughout life than other populations. In Alaska, the reasons for the disability gap are complicated. Limited economic competition, higher profit margins, expensive medical frameworks, and unique environmental, social, and demographic elements all contribute to the difficulties. Such problems create the most extreme healthcare costs in the United States, 2.5 times the national average. Instead of addressing these challenges after individuals reach the older stages of life, planning for healthy aging over a lifetime is needed to offset the risks of muscle loss, disability, and rising healthcare costs. Taking a critical look at traditional food intake is becoming more important as an attempt to hold off increasing health risks in Indigenous populations.

It is not known how free-range wild game of the Alaska Native traditional foods might affect sarcopenia, which is the age-related loss of lean tissue mass, strength, and function. Muscle, made up of proteins, is in a constant state of turnover; building up and breaking down. Whole-body protein synthesis (PS) and protein breakdown (PB) are always occurring. A healthy, steady state of lean tissue mass is a result of adequate diet and/or physical activity. Both have declined dramatically and quickly in the Alaska Indigenous population, while migration from traditional lifestyles and food consumption has also taken place. For PS to occur as a result of nutrient intake, essential amino acids (EAA’s) must be present in sufficient amounts. The wild game of the Alaska Native traditional diet provides proteins with EAA’s that are necessary for PS to be greater than PB, and create a higher net balance of protein (NB).

Hypothesis: NB will be higher in FR compared to CB; due to existing differences in the total amount of protein in FR.

Study Aim #1: to compare the feeding-induced response of equivalent amounts of free-range reindeer (FR) and commercial beef (CB) on protein metabolism using stable isotope methodology.

Who can participate?
Males and females of any ethnic background, between the ages of 20 and 70 years with a BMI of 20-28 were considered. Volunteers with a pacemaker, diabetes, or chronic inflammatory condition will not be accepted. Volunteers taking any type of medication or supplement could affect glucose metabolism cannot participate. Those with active cancer, taking corticosteroids by mouth, injection, or trans-dermally are not eligible. If the study physician recognizes any other disease that would place them at increased risk, those volunteers would not be accepted.

What does the study involve?


What are the possible benefits and risks of participating?
Study participants acquire knowledge about their health, including body composition, lipid profiles, and protein responses to reindeer and ground beef.

Where is the study run from?
Clinical Research and Imaging Facility, Alaska (USA)

When is the study starting and how long is it expected to run for?
May 2017 to June 2019

Who is funding the study?
The National Institute of General Medical Sciences of the National Institutes of Health (NIH) under award numbers UL1GM118991, TL4GM118992, or RL5GM118990 and an Institutional Development Award under grant number P20GM130443

Who is the main contact?
Dr Robert Coker, rcoker@alaska.edu

Contact information

Dr Robert Coker
Scientific

Box 75700
2140 Koyukuk
Fairbanks
99775-7000
United States of America

ORCiD logoORCID ID 0000-0002-1037-9339
Phone +1 907 474-6701
Email rcoker@alaska.edu

Study information

Study designInterventional randomized cross over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)School
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleIngestion of free-range reindeer promotes higher net protein balance compared to commercial beef
Study acronymFRCB
Study objectivesIngestion of 2 ounces of free-range reindeer will promote greater whole-body protein net balance than 2 ounces of commercial beef.
Ethics approval(s)Approved 05/04/2017, University of Alaska Fairbanks Institutional Review Board (PO Box 757270, Fairbanks, AK 99775-7270; ), ref: #749396
Health condition(s) or problem(s) studiedHealthy Individuals
InterventionThe acute response to ingestion of 2 oz of free-range reindeer meat compared to 2 oz of commercial beef was evaluated using a randomized, crossover experimental design and stable isotope methodology in healthy male and female participants.

Participants ingested reindeer or commercial beef in conjunction with isotopic tracer infusions of phenylalanine and tyrosine. Whole-body protein synthesis, protein breakdown and net protein balance were determined using the isotopic enrichments of phenylalanine and tyrosine as measured by gas chromatography-mass spectrometry. Amino acid concentrations were measured by liquid chromatography-electrospray ionization-mass spectrometry.
Intervention typeOther
Primary outcome measureWhole-body protein synthesis, protein breakdown and protein balance measured using the isotopic enrichments of phenylalanine and tyrosine as measured by gas chromatography-mass spectrometry over a seven-hour period
Secondary outcome measuresPlasma essential amino acids concentration measured using by liquid chromatography-electrospray ionization-mass spectrometry over a seven-hour period
Overall study start date04/05/2017
Completion date04/06/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
SexBoth
Target number of participantsMaximum number of 15; target of at least 6
Total final enrolment8
Key inclusion criteria1. Aged 20 - 70 years
2. BMI range of 20-38 kg/m²
Key exclusion criteria1. Have a pacemaker
2. Previously diagnosed diabetes
3. Chronic inflammatory condition
4. Taking any type of medication or supplement that may affect glucose metabolism
5. Active cancer or malignancy
6. Taking corticosteroids by mouth, injection or trans-dermally
7. Females who test positively for pregnancy
8. Any other disease that would place them at increased risk of harm if they were to participate, at the discretion of the study physician
Date of first enrolment04/05/2017
Date of final enrolment11/05/2018

Locations

Countries of recruitment

  • United States of America

Study participating centre

Clinical Research and Imaging Facility
PO Box 75700
2140 Koyukuk Drive
Fairbanks
99775-7000
United States of America

Sponsor information

National Institutes of Health
University/education

9000 Rockville Pike
Bethesda
20892
United States of America

Phone +1 (301) 496-4000
Email info@nigms.nih.gov
Website http://www.nih.gov/
ROR logo "ROR" https://ror.org/01cwqze88

Funders

Funder type

Government

National Institutes of Health
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America

Results and Publications

Intention to publish date06/01/2020
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 planTthe datasets during and/or analyzed during the current study are/will be available upon request for a period of at least 5 years. Please contact Robert Coker at rcoker@alaska.edu and/or 907 474-6701 for electronic data and data analysis and/or information regarding participant consent and institutional review board documentation.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2020 27/04/2020 Yes No

Editorial Notes

05/05/2020: Trial’s existence confirmed by University of Alaska Fairbanks Institutional Review Board.