Preserving Muscle Mass and Function in Bedridden Older Adults

NCT01846130 | Completed DMC

• 1 other identifier: 11-191
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose that low-intensity exercise and supplementing daily meals with leucine or whey will independently and synergistically reduce the deleterious effects of inactivity on skeletal muscle and facilitate recovery during rehabilitation.

Conditions

Bed Rest

Keywords

Bed rest,

Outcome Measures

Primary Outcomes (3)

• Change in lean leg mass from baseline following seven days of bed rest and seven days of rehabilitation. (Morphologic primary measure)

  The lower body musculature is primarily affected by physical inactivity (19). Lean leg mass will be determined by segmental dual energy x-ray absorptiometry (iDXA:General Electric, Lunar, Madison, WI). The whole body scan will be divided in sub-regions for analysis.

  Study day 3, 11, 18, 39

• Change in stair climbing power test from baseline following seven days of bed rest and seven days of rehabilitation (Primary functional outcome)

  Loss of leg muscle power occurs during prolonged bed rest (-14.4+4 % in 10 days)and is a key factor contributing to impaired mobility, balance and functional capacity. Climbing power will be calculated as the time to ascend 10 steps \[Power = (Distance/Time) x Body Weight\].

  Study day 3, 11, 18, 39

• Change in mixed muscle fractional synthesis rate (FSR) from baseline following seven days of bed rest and seven days of rehabilitation (Primary metabolic outcome)

  Mixed muscle FSR will be calculated by measuring the direct incorporation of a stable isotope of phenylalanine into protein using the precursor-product model.

  Study day 4, 11, 18

Secondary Outcomes (9)

• Change in cell signaling from baseline following seven days of bed rest and seven days of rehabilitation (Secondary metabolic measure)

  Study day 4, 11, 18

• Change in hormones and cytokines from baseline following seven days of bed rest and seven days of rehabilitation (Secondary Metabolic measure)

  Study day 3, 11, 18

• Change in quantitative real-time polymerase chain reaction (PCR) analysis of MAFbx/Atrogin, MuRF1 and Ubiquitin from baseline following seven days of bed rest and seven days of rehabilitation (Secondary metabolic measure)

  Study day 4, 18

• Change in protein abundance of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and Actin Fragments from baseline following seven days of bed rest and seven days of rehabilitation. (Secondary metabolic measure)

  Study day 3, 18

• Change in muscle fiber cross sectional area and fiber typing from baseline following seven days of bed rest and seven days of rehabilitation(secondary morphologic measure)

  Study day 4, 11, 18

Study Arms (7)

Control

NO INTERVENTION

Control bed rest group

Leucine

EXPERIMENTAL

Leucine will be administered in mixed meal 3 times a day at 0.06g/kg lean body mass/meal

Dietary Supplement: Leucine

Exercise

EXPERIMENTAL

Daily bouts of low intensity, bed-based exercise for 30 min/day @ 70% of stress test determined maximal heart rate.

Behavioral: Exercise

Leucine + Exercise

EXPERIMENTAL

Leucine (0.06 g/kg lean body mass/meal, 3 meal/day) and exercise daily bouts of low intensity, bed-based exercise for 30 min/day @ 70% of stress test determined maximal heart rate.

Dietary Supplement: Leucine; Behavioral: Exercise

Whey protein

EXPERIMENTAL

22 g of whey isolate 3x a day (with meals)

Dietary Supplement: Whey protein

Whey protein + exercise

EXPERIMENTAL

22 g whey isolate 3x day (with meals) and daily bouts of low intensity, bed-based exercise for 30 min/day @ 70% of stress test determined maximal heart rate

Behavioral: Exercise; Dietary Supplement: Whey protein

Skewed

NO INTERVENTION

Protein intake is distributed similar to typical American diet with low protein intake at breakfast, intermediate at lunch and high at dinner.

Interventions

Leucine DIETARY_SUPPLEMENT

Leucine; Leucine + Exercise

Exercise BEHAVIORAL

Exercise; Leucine + Exercise; Whey protein + exercise

Whey protein DIETARY_SUPPLEMENT

Whey protein; Whey protein + exercise

Eligibility Criteria

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

You may qualify if:

• Age between 60-80
• Ability to sign informed consent
• Ability to pass a mini-mental status exam
• Free-living, prior to admission

You may not qualify if:

• Subjects with uncontrolled metabolic disease
• A glomerular filtration rate (GRF) \<65 mL/min/1.73m2 or evidence of kidney disease or failure
• Subjects with vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia \> 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries.
• Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of deep vein thrombosis (DVT) or PE).
• Subjects with chronically elevated systolic pressure \>170 or a diastolic blood pressure \> 100.
• Subjects with implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
• Subjects with recently (6 months) treated cancer other than basal cell carcinoma
• Any subject currently on a weight-loss diet or a body mass index \> 30 kg/m2.
• A history of \> 20 pack per year smoking and/or inability to abstain from smoking for duration of study
• Any subject that is HIV-seropositive or has active hepatitis
• Recent anabolic or corticosteroids use (within 3 months).
• Subjects with hemoglobin or hematocrit lower than accepted lab values.
• Dementia, agitation/aggression disorder
• History of stroke with motor disability
• A recent history (\<12 months) of GI bleed

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Unversity of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Interventions

Leucine; Exercise; Whey Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Doug Paddon-Jones, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 3, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 24, 2019

Record last verified: 2018-04

Locations

US (1)