Sarcopenic ObesityNCT02379026
Lifestyle Modifications for the Treatment of Sarcopenic Obesity
A study testing Protein Drink/Diet, Exercise and Vitamin D3 in people with Sarcopenic Obesity and Sarcopenia, run by Queen Margaret University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity, Sarcopenia, Obesity
- What is being tested?
- Protein Drink/Diet, Exercise and Vitamin D3
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Independent living community-dwellers
- Sarcopenic
- Obese
- Montreal Cognitive Assessment test (MoCA) score > or = 26
Who cannot join
- Use of pacemaker
- Lactose intolerance
- Parkinson's disease
- Unmanaged pain
- Severe osteoporosis or arthritis
- Use of corticosteroids
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications
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.
Read the 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
- Being tested
- Protein Drink/Diet, Exercise, Vitamin D3
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein Drink/DietDietary 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.
ExerciseBehavioural
Participants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour.
Vitamin D3Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise & Protein Drink/Diet | Experimental | 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. Receives: Dietary Supplement: Protein Drink/Diet; Behavioral: Exercise; Dietary Supplement: Vitamin D3 |
| Exercise | Active comparator | 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. Receives: Behavioral: Exercise; Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mass
Assess changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis at baseline, week 10 and week 16.
Measured: Baseline, 10 weeks, 16 weeks
Body fat mass
Assess changes in body fat mass (in kg) using bioelectrical impedance analysis at baseline, week 10 and week 16.
Measured: Baseline, 10 weeks, 16 weeks
Secondary outcomes (6)
Physical Performance
Assess changes in Physical performance using the Short Physical Performance Battery test (SPPB) with a maximum score of 12.
Measured: Baseline, 10 weeks, 16 weeks
Dynamic Balance
Assess changes in dynamic balance using the 1-Arm Reach test (measured in cm).
Measured: Baseline, 10 weeks, 16 weeks
Functional Mobility
Assess changes in functional mobility using the timed (in seconds) Get Up-and-go test for 6 meters.
Measured: Baseline, 10 weeks, 16 weeks
Health related quality of life
Assess changes in health related quality of life using the Rand SF-36 questionnaire.
Measured: Baseline, 16 weeks
Central adiposity
Assess changes in central adiposity by measuring the Sagittal Abdominal Diameter (in cm)
Measured: Baseline, 10 weeks, 16 weeks
Handgrip strength
Assess changes in handgrip strength (in kg) using a handgrip dynamometer
Measured: Baseline, 10 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Christos Theodorakopoulos, Queen Margaret University
- Investigators
- Elaine Bannerman, PhD, Study director, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379026
- Sponsor's protocol ID
- QueenMU
- Status last verified
- Apr 2016
- First submitted
- 27 Feb 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications
- ClinicalTrials.gov ID
- NCT02379026
- Acronym / sponsor ID
- QueenMU
- Conditions
- Sarcopenic Obesity, Sarcopenia, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise & Protein Drink/Diet | Experimental | Dietary Supplement: Protein Drink/Diet, Behavioral: Exercise, Dietary Supplement: Vitamin D3High-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. |
| Exercise | Active comparator | Behavioral: Exercise, Dietary Supplement: Vitamin D3A 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Independent living community-dwellers
- Sarcopenic
- Obese
- Montreal Cognitive Assessment test (MoCA) score > or = 26
Key exclusion criteria (13 listed)
- Use of pacemaker
- Lactose intolerance
- Parkinson's disease
- Unmanaged pain
- Severe osteoporosis or arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein Drink/Diet1.2 - 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. | Dietary supplement | Exercise & Protein Drink/Diet |
| ExerciseParticipants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour. | Behavioural | Exercise, Exercise & Protein Drink/Diet |
| Vitamin D31 tablet of Vitamin D3 (25 micrograms) will be taken on 3 non-consecutive days/ week to achieve a weekly intake of 75 micrograms. | Dietary supplement | Exercise, Exercise & Protein Drink/Diet |
Primary outcome
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.
Body fat mass
Time frame: Baseline, 10 weeks, 16 weeks
Assess changes in body fat mass (in kg) using bioelectrical impedance analysis at baseline, week 10 and week 16.
6 secondary outcomes
Physical Performance
Time frame: Baseline, 10 weeks, 16 weeks
Dynamic Balance
Time frame: Baseline, 10 weeks, 16 weeks
Functional Mobility
Time frame: Baseline, 10 weeks, 16 weeks
Health related quality of life
Time frame: Baseline, 16 weeks
Central adiposity
Time frame: Baseline, 10 weeks, 16 weeks
Handgrip strength
Time frame: Baseline, 10 weeks, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Bannerman, PhD study director
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Drink/Diet, Exercise and Vitamin D3 in people with Sarcopenic Obesity and Sarcopenia, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle mass (time frame: Baseline, 10 weeks, 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.