- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282603
Nutritional Strategies for Metabolic Health in Aging (NSMH)
April 7, 2022 updated by: Robert "Trey" H. Coker, University of Alaska Fairbanks
Sarcopenic obesity in older individuals presents a clinical conundrum without an effective therapeutic strategy.
This study will determine the impact of precision amino acid delivery as part of a meal replacement (EMR) during weight loss on the preservation of lean tissue and improvements in metabolic health and physical function in older obese adults.
Following weight loss, the investigators will examine whether one serving/day of EMR will sustain the above stated benefits.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The health status of the aging population is negatively affected by sarcopenic obesity as described by the progressive loss of lean tissue and an increase in adipose tissue.
This condition presents a clinical conundrum as it predisposes older obese individuals to a high risk for disability, morbidity and mortality.
Insulin resistance, chronic inflammation, elevations in intrahepatic lipid and detrimental alterations in the gut microbiome are also evident.
The application of caloric restriction-induced weight loss (CRWL) used to address these health risks in younger individuals may exacerbate muscle wasting and increase morbidity in older adults.
Unfortunately, low fitness levels and poor compliance limit the mitigating influence of weight loss through exercise training on sarcopenic obesity.
In order to address anabolic resistance or the decreased ability to maintain protein synthesis that contributes to sarcopenic obesity, the investigators have developed a complete meal replacement that contains a mechanism-targeted profile of essential amino acids (17 grams).
This profile is designed to overcome anabolic resistance and maintain net protein balance even in the hypocaloric state.
It is our overarching hypothesis that EMR will promote the retention of lean tissue mass, and improve metabolic and functional outcomes following 12 weeks of CRWL, and that those endpoints will be sustained over a 12 week maintenance period with the once per day (q.d.) consumption of EMR.
The investigators will randomly assign older obese individuals to either EMR or an isocaloric serving of Bariatrics Advantage (meal replacement that contains 27 grams of intact protein) during these interventions.
The investigators will execute these specific aims to test our hypotheses: SA1.
Establish the importance of EMR in the preservation of lean tissue mass during CRWL.
Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry (DXA) and magnetic resonance imaging/spectroscopy (MRI/MRS) scans.
MRI/MRS will be used to measure intrahepatic lipid, and the investigators will evaluate alterations in insulin sensitivity using the HOMA score.
The investigators will measure potential changes in gut microbiota in collaboration with Dr. Duddleston at the University of Alaska Anchorage.
SA2.
Determine the influence of EMR on physical function and increased daily activity during CRWL.
Slow walking speed is a strong predictor of morbidity and mortality.
The investigators chose the 6-minute walk test to represent the primary endpoint for this aim.
The investigators will also determine alterations in gait speed, skeletal muscle power and strength and stair climbing ability, and changes in physical activity using Actigraph GT3X+ devices.
SA3.
Identify whether EMR q.d. will sustain improvements in body composition, physical function and metabolic parameters over a 12 week, maintenance period following CRWL.
Since the preservation of lean tissue mass is directly linked to optimal function and metabolic health, the investigators will measure the influence of EMR q.d. on the indices of metabolic health (ie., intrahepatic lipid, insulin sensitivity) and physical function.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alaska
-
Fairbanks, Alaska, United States, 99775
- University of Alaska Fairbanks
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60-80 years of age
- Body mass index of 30-40 kg/m2
- Participants must be capable of understanding the consent process
- Participants must be capable of signing the consent form
- Participants must have access to transportation to the clinic site
Exclusion Criteria:
- Creatinine >1.6
- Serum glutamate pyruvate transaminase >2 times normal
- Resting blood pressure above 160/90 mmHg
- Use of Gemfibrozil
- Use of corticosteroids
- Previously diagnosed diabetes (fasting blood glucose ≥ 126 mg/dl)
- History of kidney or liver disease
- Heart disease as indicated by interventional procedures
- Recent history of alcoholism
- Physical or neurological disorder that would prevent them from completing the functional tests
- Lactose intolerance
- Active cancer within the last two years
- Chronic inflammatory conditions that preclude completion of functional tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Meal Replacement
Participants randomized to this arm will consume 5 servings/day of experimental meal replacement in conjunction of 400 kcal of solid food for 12 weeks during the weight loss portion of the trial.
This will be followed by the consumption of 1 serving/day of experimental meal replacement for 12 weeks during the weight maintenance portion of the trial.
|
Participants will consume a 1,200 kcal/day diet for twelve weeks.
This is the amount of calories most commonly provided in medical weight loss programs, and considered the maximum allowable caloric intake to induce a physiologically significant weight loss.
Following the weight loss portion of the trial, participants will enter the twelve week maintenance period, during which time they will consume one serving per day in place of lunch of the same meal replacement beverage used during medical weight loss.
|
ACTIVE_COMPARATOR: Bariatrics Advantage Meal Replacement
Participants randomized to this arm will consume 5 servings/day of Bariatrics Advantage meal replacement in conjunction of 400 kcal of solid food for 12 weeks during the weight loss portion of the trial.
This will be followed by the consumption of 1 serving/day of Bariatrics Advantage meal replacement for 12 weeks during the weight maintenance portion of the trial.
|
Participants will consume a 1,200 kcal/day diet for twelve weeks.
This is the amount of calories most commonly provided in medical weight loss programs, and considered the maximum allowable caloric intake to induce a physiologically significant weight loss.
Following the weight loss portion of the trial, participants will enter the twelve week maintenance period, during which time they will consume one serving per day in place of lunch of the same meal replacement beverage used during medical weight loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean tissue mass and adipose tissue mass
Time Frame: 24 weeks for each participant
|
Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry.
|
24 weeks for each participant
|
Skeletal muscle
Time Frame: 24 weeks for each participant
|
Magnetic resonance imaging scans will be used to measure the cross sectional area of skeletal muscle
|
24 weeks for each participant
|
Metabolic health
Time Frame: 24 weeks for each participant
|
The investigators will evaluate alterations in insulin sensitivity using the HOMA score.
|
24 weeks for each participant
|
Intrahepatic lipid
Time Frame: 24 weeks for each participant
|
Magnetic resonance imaging and spectroscopy scans will be used to measure intrahepatic lipid
|
24 weeks for each participant
|
Physical function
Time Frame: 24 weeks for each participant
|
A 6-minute walk test will be used to assess changes in physical function.
|
24 weeks for each participant
|
Gut microbiome
Time Frame: 24 weeks for each participant
|
Stool kits will be provided with standardized instructions to participants for collection and transportation of stool samples.
DNA will be extracted to evaluate alterations in gut microbiota.
|
24 weeks for each participant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed step test
Time Frame: 24 weeks for each participant
|
This test will be used to evaluate dynamic balance ability.
The participant will step and down from a 4 inch bench as quickly as possible 5 times.
|
24 weeks for each participant
|
Timed floor transfer test
Time Frame: 24 weeks for each participant
|
This test will be used to evaluate mobility.
While being timed, the participant will start in the standing position, go to the supine position and return to the standing position.
|
24 weeks for each participant
|
Hand grip test
Time Frame: 24 weeks for each participant
|
This test will determine muscle strength.
The participant will grip the hand dynamometer and perform three tests, alternating with a brief rest period of 20 seconds.
|
24 weeks for each participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert H Coker, PhD, University of Alaska Fairbanks
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 18, 2019
Primary Completion (ACTUAL)
December 31, 2021
Study Completion (ACTUAL)
December 31, 2021
Study Registration Dates
First Submitted
February 5, 2020
First Submitted That Met QC Criteria
February 20, 2020
First Posted (ACTUAL)
February 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1427567-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Structured de-identified clinical data.
Restrictive protocols will be in place for human data and for data, if any, owned by Alaska Native tribes.
The PI, Data Manager and Project leader will review data requests using criteria including scientific value, appropriate research plan, protection of participant and community confidentiality, and dissemination plan.
All persons working with COBRE human data will have to sign a Confidentiality Agreement, Publication Agreement, and submit proof of current Collaborative IRB Training Initiative (CITI) certification or an equivalent approved by the UAF IRB when appropriate.
Data access is generally approved for three years, at which time data sets must be destroyed or the data access approval extended.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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