Protein and Exercise to Counteract Frailty in Older Adults
NCT ID: NCT03842579
Last Updated: 2020-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-02-13
2021-06-01
Brief Summary
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Detailed Description
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Phase 1 stabilization phase lasting one month. Participants with low protein intake (\<1.0 g/kg/day) are provided with national guidelines for daily protein intake and publicly available information material and recommended to increase their protein intake to meet the guidelines. Compliance to the recommendation/ guidelines (eating \>1.0 g/kg/day) will be evaluated by 4-day food records at the end of the stabilization phase. Only compliant participants are eligible for phase 2. Participants that are not compliant will be followed as "natural observational group" but will not be considered for the primary statistical analysis. Data collection in these participants will only include assessment of selected demographic, functional and nutritional parameters and semi-structured interviews to identify potential barriers for not improving protein intake. Semi-descriptive data will be presented if possible.
Phase 2: Three-arm randomized controlled trial lasting four months:
i) Protein-only (PROT): participants will receive milk-based protein-rich products with the aim of targeting a daily protein intake of 1.5 g/kg; ii) Exercise and Protein (EXEPROT): participants will receive the protein intervention as in the PROT-group combined with progressive explosive type heavy-resistance strength training two times per week iii) Recommendations (REC) participants receive the national nutritional recommendations for older adults and are recommended to follow these recommendations over the course of the study.
Nutritional data will be collected pre and post the stabilization phase. Collection of the primary and secondary outcomes will occur at baseline (pre phase 2) and at the 4-month follow-up (post phase 2). Nutritional assessment will also be evaluated halfway, at the 2-month follow-up.
Compliance Adherence to the exercise protocol and protein supplementation is recorded during the study. For the exercise protocol adherence will be considered as achieving minimum to 75% of valid training sessions, considered as minimum 70% of the exercises planned for each session. For the protein supplementation, adherence will be evaluated as daily protein intake of ≥ 1.35 g/kg (estimated from 24 hours recall and four-day food records) at the 2-month follow-up and at the 4-months follow-up. Compliance will also be estimated from during each delivery of products with a set of questions (e.g. how much of the supplement is consumed? Any changes to the habitual food intake?) and regular phone follow-ups. If participants are unable to reach the protein target additional face to face or phone interview will be planned to support adherence. For the REC-group adherence is defined as following the recommended intake of protein (1.0-1.3 g/kg/day).
Sample size and statistics Lower leg muscle power is the primary outcome of this study. Due to lack of studies similar to this study design (e.g. age and frailty status of the participants, type of exercise and level of protein supplementation) the investigators have calculated sample size using a combination of studies and methods. Based on findings from a 2017 study the effect of 12-weeks of protein supplementation (two daily supplements of 20 g milk protein) in combination with resistance training in +80-year-old healthy adults increased muscle power by 15% (SEM ± 5%) in comparison with -7% (SEM ± 6%) in the control group (receiving protein supplementation only). A result from a 2018 study indicate that 12 weeks of nutritional supplementation (0.8 g/kg/day, 1.2 g/kg/day or 1.5 g/kg/day) to pre-frail or frail older adults \>70 years resulted in an increase in muscle mass (estimated by Dual energy X-ray Absorptiometry, DXA) of approximately 4% in the group receiving 1.5 g/kg/day. Unpublished data from the investigators research group show that change in muscle mass (estimated by DXA) accounted for 1,95% of the change in muscle power in older adults following 12 weeks of resistance training. Hence, the estimated effect of an increase in muscle mass of 4% on muscle power is 7,8%. Adding this to the results from the 2017 study gives an estimated change on 0,8% in the PROT-group. Assuming, that the change in muscle mass are comparable in the three groups the investigator therefore expect a change in muscle power of 15%, 0,8% and -7% with a standard deviation (SD) of 30 in the EXEPROT-, PROT- and REC-group, respectively.
Setting a power of 0.8 sample size with 37 participants in each arm should be enough to detect a significant difference in muscle power (significance level at 0.05). Adding 25% to account for dropouts a total of 150 participants is needed.
Intention-to-treat analysis will be performed. In addition, per-protocol analysis of participants that are compliant to the protocol will be performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise and Protein (EXEPROT)
Participants in EXEPROT receive: a high-protein diet combined with Resistance training. The high-protein diet is based on milk-based protein-rich products to supplement the habitual diet (corresponding to a protein intake of 1.5 g/kg/day). 4-day food records are used to estimate the needed protein. Of the shelf-products (e.g. milk, cheese) are used considering the individually preferences. Products are delivered once a week. The training intervention includes progressive explosive type heavy-resistance training two times per week. The intervention runs for 16 weeks. Adherence to the training protocol is monitored at each session. Adherence with the nutrition protocol is monitored daily plus at phone follow-ups where participants are asked about e.g. appetite, weight, habitual intake.
Resistance training
Supervised progressive explosive type heavy-resistance training two times per week
High-protein diet
Daily supplementation with milk-based protein-rich products
Protein-only (PROT)
Participants in PROT-group receive the nutritional intervention: The high-protein diet.
The diet is based on daily milk-based protein-rich products to supplement the habitual diet (corresponding to a total protein intake of 1.5 g/kg/day). The needed amount of protein supplementation is estimated from 4-day food records. Of the shelf-products (e.g. milk, skyr, cheeses) are used considering the individually preferences. Products will be delivered once a week at the home of the participant. The intervention runs for 16 weeks.
Adherence with the nutrition protocol is monitored daily (registration of compliance with the dietary plan) as well as at phone follow-ups where participants are asked about e.g. changes in appetite, weight, and habitual intake.
High-protein diet
Daily supplementation with milk-based protein-rich products
Recommendations (REC)
Participants in the REC-Group receive the comparative intervention: Recommendations.
The official national dietary recommendations for adults \>65 years, developed by the Ministry of Environment and Food of Denmark, and related materials is given to the participants and they are encouraged to follow the guidelines (recommending a protein intake of 1.0-1.3 g/kg/day). The intervention runs for 16 weeks.
During the intervention all groups will receive two seminars on specific topics related to healthy ageing (e.g. talks on physical activity, sedentary behaviour, and nutrition).
Recommendations
Provided with the official national recommendations on nutrition
Interventions
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Resistance training
Supervised progressive explosive type heavy-resistance training two times per week
High-protein diet
Daily supplementation with milk-based protein-rich products
Recommendations
Provided with the official national recommendations on nutrition
Eligibility Criteria
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Inclusion Criteria
* Pre-frail or frail (evaluated by the physical frailty questionnaire, SHARE-FI75+)
* Intact cognitive function (Mini Mental State Evaluation ≥4)
* Medically stable evaluated by medical screening including blood sample
* Able to participate in group-based exercise without personal assistance
* Able to understand, read and write Danish
Exclusion Criteria
* On a weight losing diet
80 Years
ALL
No
Sponsors
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Metropolitan University College
OTHER
Municipality of Odense, Denmark
UNKNOWN
Arla Foods
INDUSTRY
University of Southern Denmark
OTHER
Responsible Party
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Paolo Caserotti
Professor and Head of Center for Active and Healthy Ageing
Principal Investigators
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Paolo Caserotti, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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University of Southern Denmark
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Bechshoft RL, Malmgaard-Clausen NM, Gliese B, Beyer N, Mackey AL, Andersen JL, Kjaer M, Holm L. Improved skeletal muscle mass and strength after heavy strength training in very old individuals. Exp Gerontol. 2017 Jun;92:96-105. doi: 10.1016/j.exger.2017.03.014. Epub 2017 Mar 28.
Park Y, Choi JE, Hwang HS. Protein supplementation improves muscle mass and physical performance in undernourished prefrail and frail elderly subjects: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):1026-1033. doi: 10.1093/ajcn/nqy214.
Buhl SF, Beck AM, Christensen B, Caserotti P. Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial. Trials. 2020 Jul 11;21(1):637. doi: 10.1186/s13063-020-04572-z.
Other Identifiers
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S-20180048
Identifier Type: OTHER
Identifier Source: secondary_id
S-20180048
Identifier Type: -
Identifier Source: org_study_id
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