Nutritional Strategies for Metabolic Health in Aging

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    48
  • sponsor
    University of Alaska Fairbanks
Updated on 18 April 2021

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.

Details
Condition Sarcopenic Obesity
Treatment Weight Loss and Weight Maintenance
Clinical Study IdentifierNCT04282603
SponsorUniversity of Alaska Fairbanks
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-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
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