Influence of amino acids on muscle preservation and functional improvements in obese, elderly adults
| ISRCTN | ISRCTN15814848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15814848 |
| Secondary identifying numbers | 1427567-13 |
- Submission date
- 11/02/2021
- Registration date
- 12/02/2021
- Last edited
- 03/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Muscle atrophy (when muscles waste away) and obesity increase the risk of disability and death in the elderly. Recent studies have demonstrated that certain essential amino acids that make up protein may help prevent muscle loss and even improve overall metabolism. The aim of this study is to compare the influence of two different types of meal replacements (ie., one with individual amino acids and one with protein alone) consumed once a day on the preservation of muscle and reduction of excess adipose (fat) tissue in older, obese individuals.
Who can participate?
Individuals from all racial, ethnic and/or cultural backgrounds between the ages of 60-85 with a body mass index of 26-40 kg/m²
What does the study involve?
Participants are randomly assigned to consume an Experimental Meal Replacement or Optifast once a day for 4 weeks. They are asked to visit the clinic for measurement of muscle and fat, physical function, and metabolic risk factors like cholesterol before and immediately following supplementation.
What are the possible benefits and risks of participating?
If proven to be effective, the Experimental Meal Replacement may help older individuals maintain or even improve their functional independence while reducing the risk of metabolic diseases. There were no anticipated risks to participants.
Where is the study run from?
University of Alaska Fairbanks (USA)
When is the study starting and how long is it expected to run for?
August 2017 to December 2018
Who is funding the study?
Essential Blends, LLC (USA)
Who is the main contact?
Robert H. Coker, PhD
rcoker@alaska.edu
Contact information
Public
PO Box 757000
Fairbanks
99775
United States of America
 ORCID ID |
0000-0002-1037-9339 |
|---|---|
| Phone | +1 (0)907 474 6701 |
| rcoker@alaska.edu |
Study information
| Study design | Double-blind parallel randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Once/day provision of essential amino acid enriched meal replacement improves body composition and physical function in obese elderly: a randomized controlled trial |
| Study acronym | EAAIMF |
| Study objectives | It is hypothesized that an essential amino acid-enriched meal replacement (EMR) would promote improvements in body composition, skeletal muscle, intrahepatic lipid and physical function compared to an isocaloric commercially available meal replacement (ie., Optifast®) in obese elderly individuals. |
| Ethics approval(s) | Approved 17/09/2017, UAF Institutional Review Board (UAF Institutional Review Board, 909 Koyukuk Drive, Suite 212, PO Box 757270, Fairbanks, AK 99775-7270, USA; +1 (0)907 474 7800; uaf-irb@alaska.edu), ref: 986801-17 |
| Health condition(s) or problem(s) studied | Body composition, skeletal muscle, intrahepatic lipid and physical function in obese elderly individuals |
| Intervention | A computerized random number generator is used for group assignment. An individual not affiliated with this study or the academic program is responsible for blinding of the meal replacements. Individuals are randomly assigned to consume an Experimental Meal Replacement or Optifast once a day for 4 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Measured during pre-supplementation and post-supplementation visits 4 weeks apart: 1. Body weight and height measured using an electronic scale/stadiometer (Health-O-Meter, St. McCook, IL, USA) 2. Body composition measured using a dual-energy x-ray absorptiometry scanner (General Electric Lunar iDXA, Madison, WI) 3. Thigh skeletal muscle cross-sectional area and intrahepatic lipid measured using a molecular resonance imaging/spectroscopy (Toshiba Excelart/Vantage 1.5 T MRI/MRS imaging system, Canon, Ōtawara, Tochigi, Japan), muscle cross-sectional area further quantified using Osirix (Geneva, Switzerland) 4. Physical function parameters including measurements of grip strength, floor transfer time and walking distance/speed |
| Secondary outcome measures | Measured during pre-supplementation and post-supplementation visits 4 weeks apart: 1. Blood samples collected and analyzed for metabolic, lipid and hepatic blood panels by LabCorp (1626 30th Avenue, Fairbanks, AK) 2. Bone mineral density measured using a dual-energy x-ray absorptiometry scanner (General Electric Lunar iDXA, Madison, WI) |
| Overall study start date | 28/08/2017 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 37 |
| Key inclusion criteria | 1. Individuals from all racial, ethnic and/or cultural backgrounds 2. Between the ages of 60-85 years old 3. Body mass index of 26-40 kg/m² |
| Key exclusion criteria | 1. Individuals with a pacemaker or other implanted metal device or object 2. Previously diagnosed with insulin-dependent diabetes, active cancer or malignancy, or a chronic inflammatory condition 3. Individuals taking medications, supplements or corticosteroids that might influence metabolism or corticosteroids 4. Any individual with a disease or condition that places them at risk or harm to themselves or others |
| Date of first enrolment | 07/09/2017 |
| Date of final enrolment | 31/10/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
2140 Koyukuk Drive
Fairbanks
99775
United States of America
Sponsor information
Industry
PO Box 83883
Fairbanks
99708
United States of America
| Phone | +1 (0)501 358 987 |
|---|---|
| wolfefreddy@gmail.com | |
| Website | http://essentialblends.co/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Submission of data to the Journal, Nutrients. Data were presented previously to the annual meeting of The Obesity Society |
| IPD sharing plan | The de-identified datasets generated during and/or analysed during the current study are/will be available upon request from Robert H. Coker, PhD (rcoker@alaska.edu). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | 22/01/2021 | 12/05/2022 | No | No | |
| Results article | 01/10/2022 | 03/10/2022 | Yes | No |
Editorial Notes
03/10/2022: Publication reference added.
12/05/2022: The following changes have been made:
1. Preprint reference added.
2. The final enrolment number has been changed from 36 to 37.
12/02/2021: Trial's existence confirmed by the University of Alaska Fairbanks. Uploaded protocol (not peer reviewed).
