Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Robert Coker
ORCID ID
http://orcid.org/0000-0002-1037-9339
Contact details
Box 75700
2140 Koyukuk
Fairbanks
99775-7000
United States of America
+1 907 474-6701
rcoker@alaska.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRBnet 749396
Study information
Scientific title
Ingestion of free-range reindeer promotes higher net protein balance compared to commercial beef
Acronym
FRCB
Study hypothesis
Ingestion of 2 ounces of free-range reindeer will promote greater whole-body protein net balance than 2 ounces of commercial beef.
Ethics approval
Approved 05/04/2017, University of Alaska Fairbanks Institutional Review Board (PO Box 757270, Fairbanks, AK 99775-7270; ), ref: #749396
Study design
Interventional randomized cross over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Schools
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Healthy Individuals
Intervention
The 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 type
Other
Phase
Drug names
Primary outcome measure
Whole-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 measures
Plasma essential amino acids concentration measured using by liquid chromatography-electrospray ionization-mass spectrometry over a seven-hour period
Overall trial start date
04/05/2017
Overall trial end date
04/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 20 - 70 years
2. BMI range of 20-38 kg/m²
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
Maximum number of 15; target of at least 6
Total final enrolment
8
Participant exclusion criteria
1. 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
Recruitment start date
04/05/2017
Recruitment end date
11/05/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Clinical Research and Imaging Facility
PO Box 75700
2140 Koyukuk Drive
Fairbanks
99775-7000
United States of America
Sponsor information
Organisation
National Institutes of Health
Sponsor details
9000 Rockville Pike
Bethesda
20892
United States of America
+1 (301) 496-4000
info@nigms.nih.gov
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institutes of Health
Alternative name(s)
NIH
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
Tthe 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.
Intention to publish date
06/01/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://doi.org/10.1096/fasebj.2020.34.s1.02180 (added 27/04/2020)