Sarcopenic ObesityPhase 1/2NSMHNCT04282603
Nutritional Strategies for Metabolic Health in Aging
A Phase 1/2 study testing Weight Loss and Weight Maintenance in people with Sarcopenic Obesity, run by University of Alaska Fairbanks at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Weight Loss and Weight Maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alaska Fairbanks
Fairbanks, Alaska, 99775
About this study
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.
Read the 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.
- Conditions
- Sarcopenic Obesity
- Being tested
- Weight Loss and Weight Maintenance
- Keywords
- Adipose tissue, Skeletal Muscle, Physical Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss and Weight MaintenanceCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Meal Replacement | Experimental | 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. Receives: Combination Product: Weight Loss and Weight Maintenance |
| Bariatrics Advantage Meal Replacement | Active comparator | 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. Receives: Combination Product: Weight Loss and Weight Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean tissue mass and adipose tissue mass
Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry.
Measured: 24 weeks for each participant
Skeletal muscle
Magnetic resonance imaging scans will be used to measure the cross sectional area of skeletal muscle
Measured: 24 weeks for each participant
Metabolic health
The investigators will evaluate alterations in insulin sensitivity using the HOMA score.
Measured: 24 weeks for each participant
Intrahepatic lipid
Magnetic resonance imaging and spectroscopy scans will be used to measure intrahepatic lipid
Measured: 24 weeks for each participant
Physical function
A 6-minute walk test will be used to assess changes in physical function.
Measured: 24 weeks for each participant
Gut microbiome
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.
Measured: 24 weeks for each participant
Secondary outcomes (3)
Timed step test
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.
Measured: 24 weeks for each participant
Timed floor transfer test
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.
Measured: 24 weeks for each participant
Hand grip test
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.
Measured: 24 weeks for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start18 Apr 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Grant Transfer Not Approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a randomized, double blind, two arm study, where one arm receives a standard meal replacement (Bariatrics Advantage), and the other an enhanced one (ie., EMR) for 24 weeks, including a caloric restriction period of 12 weeks, and a maintenance period of 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alaska Fairbanks
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert "Trey" H. Coker, University of Alaska Fairbanks
- Investigators
- Robert H Coker, PhD, Principal investigator, University of Alaska Fairbanks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282603
- Sponsor's protocol ID
- 1427567-2
- Acronym
- NSMH
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Strategies for Metabolic Health in Aging
- ClinicalTrials.gov ID
- NCT04282603
- Acronym / sponsor ID
- NSMH / 1427567-2
- Conditions
- Sarcopenic Obesity
- Keywords
- Adipose tissue, Skeletal Muscle, Physical Function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant Transfer Not Approved
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Alaska FairbanksUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study design is a randomized, double blind, two arm study, where one arm receives a standard meal replacement (Bariatrics Advantage), and the other an enhanced one (ie., EMR) for 24 weeks, including a caloric restriction period of 12 weeks, and a maintenance period of 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental Meal Replacement | Experimental | Combination Product: Weight Loss and Weight MaintenanceParticipants 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. |
| Bariatrics Advantage Meal Replacement | Active comparator | Combination Product: Weight Loss and Weight MaintenanceParticipants 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Creatinine >1.6
- Serum glutamate pyruvate transaminase >2 times normal
- Resting blood pressure above 160/90 mmHg
- Use of Gemfibrozil
- Use of corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss and Weight MaintenanceParticipants 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. | Combination product | Bariatrics Advantage Meal Replacement, Experimental Meal Replacement |
Primary outcome
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.
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
Metabolic health
Time frame: 24 weeks for each participant
The investigators will evaluate alterations in insulin sensitivity using the HOMA score.
Intrahepatic lipid
Time frame: 24 weeks for each participant
Magnetic resonance imaging and spectroscopy scans will be used to measure intrahepatic lipid
Physical function
Time frame: 24 weeks for each participant
A 6-minute walk test will be used to assess changes in physical function.
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.
3 secondary outcomes
Timed step test
Time frame: 24 weeks for each participant
Timed floor transfer test
Time frame: 24 weeks for each participant
Hand grip test
Time frame: 24 weeks for each participant
Results and safety
The study was stopped early (reason given: Grant Transfer Not Approved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Coker, PhD principal investigator
University of Alaska Fairbanks
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Weight Loss and Weight Maintenance in people with Sarcopenic Obesity, run by University of Alaska Fairbanks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Grant Transfer Not Approved). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean tissue mass and adipose tissue mass (time frame: 24 weeks for each participant). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.