Effects of High-protein Diet Combined With Exercise to Counteract Frailty in Pre-frail and Frail Community-dwelling Older Adults: a Three-arm Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Changes from baseline lower leg muscle power at 4 months
Study Overview
Brief Summary
The purpose of this study is to determine the effects of interventions with high-protein diet alone or in combination with resistance training on muscle mechanical function (muscle power and strength), frailty status, functional performance, muscle mass and quality of life.
Detailed Description
Study design: two-phase randomized controlled trial with three arms.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors will not be informed about allocation of the participants prior to the assessment of outcomes. The participants will be informed not to give any information to outcome assessors about the result of their randomization
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Community-dwelling adults ≥ 80 years
- •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
- •Allergic/ intolerant to the interventions (kidney diseases, lactose intolerance etc.)
- •On a weight losing diet
Arms & Interventions
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.
Intervention: Resistance training (Other)
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.
Intervention: High-protein diet (Other)
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.
Intervention: High-protein diet (Other)
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).
Intervention: Recommendations (Other)
Outcomes
Primary Outcomes
Changes from baseline lower leg muscle power at 4 months
Time Frame: Baseline and 4-month follow-up
Lower leg muscle power will be assessed unilaterally using the Nottingham Leg Rig
Secondary Outcomes
- Eating Symptom Questionnaire(Baseline)
- Risk of Dysphagia(Baseline)
- Appetite(Baseline)
- Changes from baseline countermovement jump muscle power at 4 months(Baseline and 4-month follow-up)
- Changes from baseline leg press and handgrip muscle strength at 4 months(Baseline and 4-month follow-up)
- Changes from baseline physical frailty status at 4 months(Baseline and 4 months follow-up)
- Changes from baseline Short Physical Performance Battery test at 4 months(Baseline and 4-month follow-up)
- Changes from baseline anthropometry waist and hip circumference at 4 months(Baseline and 4 months follow-up)
- Changes from baseline body weight at 4 months(Baseline and 4 months follow-up)
- Changes from baseline lean and fat mass at 4 months(Baseline and 4 months follow-up)
- Changes from baseline lean and fat mass and bone mineral density) to 4 months(Baseline and 4 months follow-up)
- Changes from baseline Health-related quality of life to 4 months(Baseline and 4-months follow-up)
- Changes from baseline activities of daily living to 4 months(Baseline and 4-months follow-up)
- Changes from baseline pain to 4 months(Baseline and 4-months follow-up)
- Chenages from baseline Objective measures of Physical activity, sedentary behaviour, nap and sleep to 4 months(Baseline and 4-months follow-up)
- Changes from baseline Dietary intake to 4 month(Baseline and 4-months follow-up)
- Changes from baseline fatigue and fatigability to 4 months(Baseline and 4-months follow-up)
- Changes from baseline Walking speed to 4 months(Baseline and 4 months follow-up)
- Changes from baseline Stand and reach to 4 months(Baseline to 4 months follow-up)
- Changes from baseline Upper body ball throwing to 4 months(Baseline to 4 months follow-up)
- Changes from baseline Nutritional status to 4 months(Baseline and 4 months follow-up)
- Changes in Risk of poor protein intake to 4 months(Baseline and 4 months)
- Changes from baseline fear of falling to 4 months(Baseline and 4-months follow-up)
- Changes from baseline Blood markers to 4 months(Baseline and 4-months follow-up)
- Changes from baseline Self-reported Physical activity & sedentary behaviour to 4 months(Baseline and 4-months follow-up)
- 24 hours recall(pre phase 1)
- Changes from baseline Walking distance to 4 months(Baseline and 4 months follow-up)
- Changes from baseline Rising from laying position to 4 months(Baseline to 4 months follow-up)
Investigators
Paolo Caserotti
Professor and Head of Center for Active and Healthy Ageing
University of Southern Denmark