Condition category
Not Applicable
Date applied
24/04/2020
Date assigned
07/05/2020
Last edited
05/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

http://www.nih.gov/

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)

Publication citations

Additional files

Editorial Notes

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