Nutritional Strategies for Metabolic Health in Aging

Sarcopenic Obesity Clinical Trial

— NSMH  

Official title:

Nutritional Strategies for Metabolic Health in Aging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04282603
• Other study ID #: 1427567-2
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Sarcopenic Obesity

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