Lifestyle Modifications for the Treatment of Sarcopenic Obesity

Obesity Clinical Trial

Official title:

Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02379026
• Other study ID #: QueenMU
• Status: Active, not recruiting
• Phase: N/A
• First received: February 27, 2015
• Last updated: April 2, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Sarcopenia
• Sarcopenic Obesity

Intervention

Dietary Supplement:
• Protein Drink/Diet
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.

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

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

Locations

Country	Name	City	State
United Kingdom	Queen Margaret University	Musselburgh

Sponsors (2)

Lead Sponsor	Collaborator
Queen Margaret University	University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary intake	Assess changes in dietary intakes using 3-day recorded diet diaries from baseline to week 16	Baseline, 16 weeks	No
Other	Serum vitamin D (25-OH) levels	Assess changes in serum vitamin D levels at baseline and week 16	Baseline, 16 weeks	No
Primary	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	No
Primary	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	No
Secondary	Physical Performance	Assess changes in Physical performance using the Short Physical Performance Battery test (SPPB) with a maximum score of 12.	Baseline, 10 weeks, 16 weeks	No
Secondary	Dynamic Balance	Assess changes in dynamic balance using the 1-Arm Reach test (measured in cm).	Baseline, 10 weeks, 16 weeks	No
Secondary	Functional Mobility	Assess changes in functional mobility using the timed (in seconds) Get Up-and-go test for 6 meters.	Baseline, 10 weeks, 16 weeks	No
Secondary	Health related quality of life	Assess changes in health related quality of life using the Rand SF-36 questionnaire.	Baseline, 16 weeks	No
Secondary	Central adiposity	Assess changes in central adiposity by measuring the Sagittal Abdominal Diameter (in cm)	Baseline, 10 weeks, 16 weeks	No
Secondary	Handgrip strength	Assess changes in handgrip strength (in kg) using a handgrip dynamometer	Baseline, 10 weeks, 16 weeks	No