- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02379026
Lifestyle Modifications for the Treatment of Sarcopenic Obesity
Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Musselburgh, United Kingdom, EH21 6UU
- Queen Margaret University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise & Protein Drink/Diet
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.
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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.
Participants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour.
1 tablet of Vitamin D3 (25 micrograms) will be taken on 3 non-consecutive days/ week to achieve a weekly intake of 75 micrograms.
|
Active Comparator: Exercise
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.
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Participants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour.
1 tablet of Vitamin D3 (25 micrograms) will be taken on 3 non-consecutive days/ week to achieve a weekly intake of 75 micrograms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal muscle mass
Time Frame: Baseline, 10 weeks, 16 weeks
|
Assess changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis at baseline, week 10 and week 16.
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Baseline, 10 weeks, 16 weeks
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Body fat mass
Time Frame: Baseline, 10 weeks, 16 weeks
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Assess changes in body fat mass (in kg) using bioelectrical impedance analysis at baseline, week 10 and week 16.
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Baseline, 10 weeks, 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Performance
Time Frame: Baseline, 10 weeks, 16 weeks
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Assess changes in Physical performance using the Short Physical Performance Battery test (SPPB) with a maximum score of 12.
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Baseline, 10 weeks, 16 weeks
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Dynamic Balance
Time Frame: Baseline, 10 weeks, 16 weeks
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Assess changes in dynamic balance using the 1-Arm Reach test (measured in cm).
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Baseline, 10 weeks, 16 weeks
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Functional Mobility
Time Frame: Baseline, 10 weeks, 16 weeks
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Assess changes in functional mobility using the timed (in seconds) Get Up-and-go test for 6 meters.
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Baseline, 10 weeks, 16 weeks
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Health related quality of life
Time Frame: Baseline, 16 weeks
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Assess changes in health related quality of life using the Rand SF-36 questionnaire.
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Baseline, 16 weeks
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Central adiposity
Time Frame: Baseline, 10 weeks, 16 weeks
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Assess changes in central adiposity by measuring the Sagittal Abdominal Diameter (in cm)
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Baseline, 10 weeks, 16 weeks
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Handgrip strength
Time Frame: Baseline, 10 weeks, 16 weeks
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Assess changes in handgrip strength (in kg) using a handgrip dynamometer
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Baseline, 10 weeks, 16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary intake
Time Frame: Baseline, 16 weeks
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Assess changes in dietary intakes using 3-day recorded diet diaries from baseline to week 16
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Baseline, 16 weeks
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Serum vitamin D (25-OH) levels
Time Frame: Baseline, 16 weeks
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Assess changes in serum vitamin D levels at baseline and week 16
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Baseline, 16 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Elaine Bannerman, PhD, Queen Margaret University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Obesity
- Sarcopenia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- QueenMU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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