Lifestyle Modifications for the Treatment of Sarcopenic Obesity

NCT ID: NCT02379026

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Sarcopenic Obesity; Sarcopenia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Protein Drink/Diet

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Vitamin D3

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

Vitamin D3

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Exercise

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: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Birmingham

OTHER

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Christos Theodorakopoulos

Mr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Bannerman, PhD

Role: STUDY_DIRECTOR

Queen Margaret University

Locations

Queen Margaret University

Musselburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

QueenMU

Identifier Type: -

Identifier Source: org_study_id