Protein and Exercise to Counteract Frailty in Older Adults

NCT03842579 | Unknown DMC

• 1 other identifier: S-20180048
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Frailty

Keywords

Frailty; Ageing; High-Protein diet; Protein Supplementation; Resistance Training; Strength Training; Muscle Power; Muscle Strength; Muscle Mass; Functional Performance; Nutritional Status

Outcome Measures

Primary Outcomes (1)

• Changes from baseline lower leg muscle power at 4 months

  Lower leg muscle power will be assessed unilaterally using the Nottingham Leg Rig

  Baseline and 4-month follow-up

Secondary Outcomes (28)

• Changes from baseline physical frailty status at 4 months

  Baseline and 4 months follow-up

• 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 Short Physical Performance Battery test at 4 months

  Baseline and 4-month follow-up

• Eating Symptom Questionnaire

  Baseline

Other Outcomes (9)

• Cognitive function

  Baseline and 4-months follow-up

• Gender

  Baseline

• Age

  Baseline

Study Arms (3)

Exercise and Protein (EXEPROT)

EXPERIMENTAL

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.

Other: Resistance training; Other: High-protein diet

Protein-only (PROT)

ACTIVE COMPARATOR

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.

Other: High-protein diet

Recommendations (REC)

ACTIVE COMPARATOR

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).

Other: Recommendations

Interventions

Resistance training OTHER

Supervised progressive explosive type heavy-resistance training two times per week

Exercise and Protein (EXEPROT)

High-protein diet OTHER

Daily supplementation with milk-based protein-rich products

Exercise and Protein (EXEPROT); Protein-only (PROT)

Recommendations OTHER

Provided with the official national recommendations on nutrition

Recommendations (REC)

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergic/ intolerant to the interventions (kidney diseases, lactose intolerance etc.)
• On a weight losing diet

Sponsors & Collaborators

• University of Southern Denmark: lead
• Metropolitan University College: collaborator
• Municipality of Odense, Denmark: collaborator
• Arla Foods: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

RECRUITING

Related Publications (3)

• 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.

  PMID: 28363433 BACKGROUND

• 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.

  PMID: 30475969 BACKGROUND

• 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.

  PMID: 32653012 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Resistance Training; Diet, High-Protein; Health Planning Guidelines

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Planning; Health Care Economics and Organizations

Study Officials

• Paolo Caserotti, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sussi F. Buhl, PhD.Stud

CONTACT

+45 65 50 89 24; sbuhl@health.sdu.dk

Paolo Caserotti, PhD

CONTACT

+45 65 50 34 44; PCaserotti@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Center for Active and Healthy Ageing

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: February 13, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)