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Lifestyle Modifications for the Treatment of Sarcopenic Obesity

Primary Purpose

Sarcopenic Obesity, Sarcopenia, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Protein Drink/Diet
Exercise
Vitamin D3
Sponsored by
Queen Margaret University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenic Obesity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Queen Margaret University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise & Protein Drink/Diet

Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical Performance
Assess changes in Physical performance using the Short Physical Performance Battery test (SPPB) with a maximum score of 12.
Dynamic Balance
Assess changes in dynamic balance using the 1-Arm Reach test (measured in cm).
Functional Mobility
Assess changes in functional mobility using the timed (in seconds) Get Up-and-go test for 6 meters.
Health related quality of life
Assess changes in health related quality of life using the Rand SF-36 questionnaire.
Central adiposity
Assess changes in central adiposity by measuring the Sagittal Abdominal Diameter (in cm)
Handgrip strength
Assess changes in handgrip strength (in kg) using a handgrip dynamometer

Full Information

First Posted
February 27, 2015
Last Updated
April 2, 2016
Sponsor
Queen Margaret University
Collaborators
University of Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02379026
Brief Title
Lifestyle Modifications for the Treatment of Sarcopenic Obesity
Official Title
Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University
Collaborators
University of Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sarcopenic Obesity is associated with advanced ageing and is characterised by increased adipose tissue and loss of muscle mass, strength and/or function. The combination of sarcopenia and obesity can predispose older individuals to more functional disabilities than either of these two conditions alone, leading eventually to increased rates of morbidity and mortality. Lifestyle interventions focusing on physical activity and diet have been suggested as an effective tackling strategy. However, there is limited evidence on the efficacy of such interventions in sarcopenic obese individuals over 65 years of age. Therefore, the aim of this study is to assess the impact of a high protein energy-restriction diet and a mixed exercise program on body composition, strength, functionality and quality of life in older people with sarcopenic obesity. This is a prospective randomised control trial among independent living sarcopenic obese community-dwellers. Eligible participants are people over 65y who experience increased adiposity (% body fat >28% in men and >40% in women) and low skeletal muscle index (SMI <10.75 kg/m2 in men and <6.75kg/m2 in women). Fifty (50) participants will be randomly allocated to either the exercise group (EX) or the exercise plus high protein energy-restricted diet group (EXD). Each group will undergo 3 exercise sessions/ week for a period of 16 weeks. The exercise sessions will be similar for both groups and will incorporate aerobic, resistance, balance and flexibility elements. The EXD group will receive a 500kcal-deficit diet plan and a milk-based protein supplement (ProMilk 50 by Myprotein; 50 g milk protein/ 500 ml bottle) to consume every day (at post-workout on exercise days or as a pre-bed snack on non-exercising days). The protein consumption will be in the range of 1.2-1.5 g.kg bw-1. A total weekly dose of 75mcg Vitamin D3 (3 x 25mcg) will be administered orally to all participants to avoid potential confounders associated with Vitamin D deficiency/hypovitaminosis. The primary and secondary outcomes will be evaluated at baseline, week 10 and week 16.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenic Obesity, Sarcopenia, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise & Protein Drink/Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Drink/Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
1 tablet of Vitamin D3 (25 micrograms) will be taken on 3 non-consecutive days/ week to achieve a weekly intake of 75 micrograms.
Primary Outcome Measure Information:
Title
Skeletal muscle mass
Description
Assess changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis at baseline, week 10 and week 16.
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Body fat mass
Description
Assess changes in body fat mass (in kg) using bioelectrical impedance analysis at baseline, week 10 and week 16.
Time Frame
Baseline, 10 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Physical Performance
Description
Assess changes in Physical performance using the Short Physical Performance Battery test (SPPB) with a maximum score of 12.
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Dynamic Balance
Description
Assess changes in dynamic balance using the 1-Arm Reach test (measured in cm).
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Functional Mobility
Description
Assess changes in functional mobility using the timed (in seconds) Get Up-and-go test for 6 meters.
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Health related quality of life
Description
Assess changes in health related quality of life using the Rand SF-36 questionnaire.
Time Frame
Baseline, 16 weeks
Title
Central adiposity
Description
Assess changes in central adiposity by measuring the Sagittal Abdominal Diameter (in cm)
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Handgrip strength
Description
Assess changes in handgrip strength (in kg) using a handgrip dynamometer
Time Frame
Baseline, 10 weeks, 16 weeks
Other Pre-specified Outcome Measures:
Title
Dietary intake
Description
Assess changes in dietary intakes using 3-day recorded diet diaries from baseline to week 16
Time Frame
Baseline, 16 weeks
Title
Serum vitamin D (25-OH) levels
Description
Assess changes in serum vitamin D levels at baseline and week 16
Time Frame
Baseline, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Independent living community-dwellers Sarcopenic Obese Montreal Cognitive Assessment test (MoCA) score > or = 26 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Bannerman, PhD
Organizational Affiliation
Queen Margaret University
Official's Role
Study Director
Facility Information:
Facility Name
Queen Margaret University
City
Musselburgh
ZIP/Postal Code
EH21 6UU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Lifestyle Modifications for the Treatment of Sarcopenic Obesity

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