Clinical trial NCT02379026: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenic Obesity
Sarcopenia
Obesity
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2015-03-04
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Skeletal muscle mass
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Body fat mass
timeFrame: Baseline, 10 weeks, 16 weeks
Secondary outcomes:
measure: Physical Performance
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Dynamic Balance
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Functional Mobility
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Health related quality of life
timeFrame: Baseline, 16 weeks
measure: Central adiposity
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Handgrip strength
timeFrame: Baseline, 10 weeks, 16 weeks
Other outcomes:
measure: Dietary intake
timeFrame: Baseline, 16 weeks
measure: Serum vitamin D (25-OH) levels
timeFrame: Baseline, 16 weeks
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University
Study officials:
affiliation: Queen Margaret University
name: Elaine Bannerman, PhD
role: STUDY_DIRECTOR
References: