Lifestyle Modifications for the Treatment of Sarcopenic Obesity

NCT02379026 | Unknown

• 1 other identifier: QueenMU
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of a high-protein energy-restricted diet to exercise in the treatment of sarcopenic obesity in people aged 65 and over. Half of participants will follow a hypocaloric (500 kcal deficit) high-protein (1.2 -1.5 g Protein/ kg bodyweight) diet alongside an exercise regime, while the other half will follow the same exercise regime alongside their habitual diet . All participants will consume a Vitamin D3 tablet (25micrograms) 3 times a week to achieve a weekly intake of 75 micrograms. Total duration of the intervention will be 16 weeks.

Conditions

Sarcopenic Obesity; Sarcopenia; Obesity

Outcome Measures

Primary Outcomes (2)

• Skeletal muscle mass

  Assess changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis at baseline, week 10 and week 16.

  Baseline, 10 weeks, 16 weeks

• Body fat mass

  Assess changes in body fat mass (in kg) using bioelectrical impedance analysis at baseline, week 10 and week 16.

  Baseline, 10 weeks, 16 weeks

Secondary Outcomes (6)

• Physical Performance

  Baseline, 10 weeks, 16 weeks

• Dynamic Balance

  Baseline, 10 weeks, 16 weeks

• Functional Mobility

  Baseline, 10 weeks, 16 weeks

• Health related quality of life

  Baseline, 16 weeks

• Central adiposity

  Baseline, 10 weeks, 16 weeks

Other Outcomes (2)

• Dietary intake

  Baseline, 16 weeks

• Serum vitamin D (25-OH) levels

  Baseline, 16 weeks

Study Arms (2)

Exercise & Protein Drink/Diet

EXPERIMENTAL

High-protein (1.2-1.5 g protein per kg bodyweight; a milk-based protein drink will provide 50 g protein/day) energy-restricted (500 kcal deficit) diet and a multimodal exercise program (balance, flexibility, aerobic, resistance) 3 times/week, each lasting 1 hour. 1 tablet of Vitamin D3 (25 micrograms) x three days/week. Total duration 16 weeks.

Dietary Supplement: Protein Drink/Diet; Behavioral: Exercise; Dietary Supplement: Vitamin D3

Exercise

ACTIVE COMPARATOR

A multimodal exercise program (balance, flexibility, aerobic, resistance) will take place 3 times/week, each one lasting 1 hour. Participants in this group will follow their habitual diet. 1 tablet of Vitamin D3 (25 micrograms) x three days/week. Total duration 16 weeks.

Behavioral: Exercise; Dietary Supplement: Vitamin D3

Interventions

Protein Drink/Diet DIETARY_SUPPLEMENT

1.2 - 1.5 g of protein per kilogram bodyweight will be consumed per day. One milk-based beverage high in dairy protein (50g of protein per 500ml bottle) will be consumed every day (post-workout on exercise days, before bed on non-exercise days). A 500kcal deficit diet will be prescribed based on the individual characteristics (eg weight, age, physical activity levels) of each participant.

Exercise & Protein Drink/Diet

Exercise BEHAVIORAL

Participants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour.

Exercise; Exercise & Protein Drink/Diet

Vitamin D3 DIETARY_SUPPLEMENT

1 tablet of Vitamin D3 (25 micrograms) will be taken on 3 non-consecutive days/ week to achieve a weekly intake of 75 micrograms.

Exercise; Exercise & Protein Drink/Diet

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Independent living community-dwellers
• Sarcopenic
• Obese
• Montreal Cognitive Assessment test (MoCA) score \> or = 26

You may not qualify if:

• Use of pacemaker
• Lactose intolerance
• Parkinson's disease
• Unmanaged pain
• Severe osteoporosis or arthritis
• Use of corticosteroids
• History of pulmonary embolus or myocardial infarction within the previous 2 years
• Heart disease
• Chronic obstructive pulmonary disease
• Chronic kidney disease
• Hypertension (resting systolic pressure \>200mmHg, resting diastolic \>100mmHg)
• Acute systemic illnesses
• Any other uncontrolled physical, psychological or mental condition that either prohibits adherence to the study protocol or increases significantly the health risks for the subject.

Sponsors & Collaborators

• Queen Margaret University: lead
• University of Birmingham: collaborator

Study Sites (1)

Queen Margaret University

Musselburgh, EH21 6UU, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia; Obesity

Interventions

Exercise; Cholecalciferol

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Elaine Bannerman, PhD

  Queen Margaret University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

GB (1)