Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04282603
Other study ID # 1427567-2
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date April 18, 2019
Est. completion date December 31, 2021

Study information

Verified date April 2022
Source University of Alaska Fairbanks
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Weight Loss and Weight Maintenance
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.

Locations

Country Name City State
United States University of Alaska Fairbanks Fairbanks Alaska

Sponsors (1)

Lead Sponsor Collaborator
University of Alaska Fairbanks

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lean tissue mass and adipose tissue mass Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry. 24 weeks for each participant
Primary Skeletal muscle Magnetic resonance imaging scans will be used to measure the cross sectional area of skeletal muscle 24 weeks for each participant
Primary Metabolic health The investigators will evaluate alterations in insulin sensitivity using the HOMA score. 24 weeks for each participant
Primary Intrahepatic lipid Magnetic resonance imaging and spectroscopy scans will be used to measure intrahepatic lipid 24 weeks for each participant
Primary Physical function A 6-minute walk test will be used to assess changes in physical function. 24 weeks for each participant
Primary 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. 24 weeks for each participant
Secondary 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. 24 weeks for each participant
Secondary 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. 24 weeks for each participant
Secondary 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. 24 weeks for each participant
See also
  Status Clinical Trial Phase
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT03212391 - WAVE Study- Walking and Aging in VErona Study N/A
Recruiting NCT05289219 - Effects of Physical Exercise on Sarcopenia After Bariatric Surgery N/A
Completed NCT05143398 - Nutritional Supplementation in Sarcopenic Obesity N/A
Completed NCT04122638 - Prevalence of Sarcopenia and Sarcopenic Obesity in Older Adults
Recruiting NCT05582668 - Sarcopenia After Bariatric Surgery in Older Patients: A Cohort Study
Active, not recruiting NCT02379026 - Lifestyle Modifications for the Treatment of Sarcopenic Obesity N/A
Enrolling by invitation NCT05638035 - Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women
Recruiting NCT05477277 - Adverse Outcomes and Mortality in Liver Transplant N/A
Not yet recruiting NCT04597788 - Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss N/A
Completed NCT04771377 - Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery. N/A
Recruiting NCT03347773 - Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity N/A
Active, not recruiting NCT04272073 - A High-PRotein Mediterranean Diet and Resistance Exercise for Cardiac Rehabilitation N/A
Recruiting NCT06320158 - Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly
Completed NCT03863379 - Sarcopenic Obesity in Neurodisabilities
Recruiting NCT04221750 - Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors Phase 3
Completed NCT05918159 - Effects of Sarcopenia on General Health Status in Elderly: a Population-based Study
Completed NCT05029713 - Sarcopenic Obesity in Liver Transplanted Patients
Completed NCT03370211 - Resistance Training and Sarcopenic Obesity Elderly Women N/A
Recruiting NCT05734755 - Dietary Programme and Exercise Training in Combination or Separately on Managing Sarcopenic Obesity in Older Adults N/A