Nutritional Strategies for Metabolic Health in Aging

NCT04282603 | Terminated Phase 1

• 1 other identifier: 1427567-2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenic Obesity

Keywords

Adipose tissue; Skeletal Muscle; Physical Function

Outcome Measures

Primary Outcomes (6)

• 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

• Skeletal muscle

  Magnetic resonance imaging scans will be used to measure the cross sectional area of skeletal muscle

  24 weeks for each participant

• Metabolic health

  The investigators will evaluate alterations in insulin sensitivity using the HOMA score.

  24 weeks for each participant

• Intrahepatic lipid

  Magnetic resonance imaging and spectroscopy scans will be used to measure intrahepatic lipid

  24 weeks for each participant

• Physical function

  A 6-minute walk test will be used to assess changes in physical function.

  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.

  24 weeks for each participant

Secondary Outcomes (3)

• Timed step test

  24 weeks for each participant

• Timed floor transfer test

  24 weeks for each participant

• Hand grip test

  24 weeks for each participant

Study Arms (2)

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.

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.

Combination Product: Weight Loss and Weight Maintenance

Interventions

Weight Loss and Weight Maintenance COMBINATION_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.

Bariatrics Advantage Meal Replacement; Experimental Meal Replacement

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alaska Fairbanks: lead

Study Sites (1)

University of Alaska Fairbanks

Fairbanks, Alaska, 99775, United States

Location

Study Officials

• Robert H Coker, PhD

  University of Alaska Fairbanks

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Eligible volunteers will be randomly assigned to one of two groups: Experimental Meal Replacement or Bariatrics Advantage Meal Replacement. Only the statistician will know to which group a subject is assigned. Identifying information with regard to randomization of participants to their assigned group will be stored in a binder with Case Report Forms. A master list linking participants to a number and their assigned group will be kept in a password protected file in the database by the study statistician. This process will ensure a high degree of scientific rigor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biology

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 25, 2020
• Study Start: April 18, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)