Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly

• ClinicalTrials.gov Identifier: NCT03862937
• Recruitment Status: Completed
• First Posted: March 5, 2019
• Last Update Posted: July 21, 2020
• Sponsor: Federal University of Health Science of Porto Alegre
• Information provided by (Responsible Party): Cláudia Dornelles Schneider, Federal University of Health Science of Porto Alegre

Study Description

Brief Summary:

The increase in life expectancy of the world population is associated with a higher incidence of diseases, leading to functional incapacity and dependence in old age. Aging is usually accompanied by progressive loss of muscle mass, muscular strength and functional capacity, possibly exacerbated by inactivity and low protein and energy consumption of elderly individuals. However, the response to strength training, as well as the daily recommendation of protein and other factors related to sarcopenia in this population seem not to be well understood. Objective: To evaluate the effect of protein intake and resistance training on body composition, muscle strength and functional capacity in the elderly. METHODS: A randomized placebo-controlled clinical trial will be conducted with 38 elderly people, ≥ 60 years old, sedentary, and body mass index between 22 and 30 kg / m2. All those who agree to participate will be randomized into two groups (intervention or placebo) and will undergo an initial assessment consisting of food consumption analysis through the application of the three-day food record, assessment of muscle thickness of the thigh and arm by muscle ultrasonography, evaluation of body composition by dual energy X-ray absorptiometry (DEXA), dynamic maximal strength (1RM) test of knee extension and elbow flexion, peak torque test of knee extension, functional capacity tests and quality of life questionnaire (SF-36). The elderly will participate in resistance training for 12 weeks, two session per week. The intervention group will be supplemented with whey protein isolate (2x / day - 20g for breakfast and 20g for dinner) and the placebo group will receive maltodextrin (2x / day - 20g for breakfast and 20g for dinner). All outcomes will be assessed before and after the 12-week resistance training period.

Condition or disease	Intervention/treatment	Phase
Elderly; Sarcopenia	Dietary Supplement: Exercise training + whey protein; Other: Exercise training + placebo (maltodextrin)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
• Actual Study Start Date: March 3, 2019
• Actual Primary Completion Date: December 20, 2019
• Actual Study Completion Date: December 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; The experimental group will perform 12 weeks of strength training twice a week associated with whey protein supplementation.	Dietary Supplement: Exercise training + whey protein; Whey protein (2x / day - 20g for breakfast and 20g for dinner).
Placebo Comparator: Placebo; The placebo group will perform 12 weeks of strength training twice a week associated with maltodextrin supplementation.	Other: Exercise training + placebo (maltodextrin); Maltodextrin (2x / day - 20g for breakfast and 20g for dinner).

Outcome Measures

Primary Outcome Measures :

1. Densitometry by dual energy X-ray absorptiometry (DEXA) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation). ]
   Measure body composition, such as total fat mass (kg), total fat-free mass (kg), and fat-free mass in the thigh (kg) will be assessed using Dual Energy X-Ray Absorption Densitometry (HXD) (Hologic Discovery W, USA).
2. Ultrasonography change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation). ]
   The evaluation of muscle thickness of the quadriceps femoris muscles, as well as the brachial and brachial biceps will be done by means of an image obtained using the Ulio XG ultrasound device (Toshiba, Japan).
3. Muscular strength (peak of torque) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation). ]
   The torque production rate will be calculated from the torque-time curves obtained during a maximal voluntary isometric contraction of knee extension performed on an isokinetic dynamometer (Cybex, Ronkonkoma, USA).
4. Muscular strength (1-RM) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12 weeks resistance training and supplementation). ]
   The 1-RM tests (1 maximum repetition test) of knee extension and elbow flexion will be performed in an extensor chair and Scott bench, respectively (Mark Können Gym, China), bilaterally.
5. Functional capacity (sit and stand up test) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation). ]
   The number of sit and stand movements in the chair will be evaluated in 30 seconds.
6. Functional capacity (timed up and go test) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation). ]
   The task will be to walk a three-meter course, get around a cone, go back and sit in the chair. The result will be expressed in seconds.
7. Functional capacity (stair climbing test) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation). ]
   Task to climb a flight of stairs at a comfortable speed and without the aid of the handrail and the time will be measured in seconds.

Secondary Outcome Measures :

1. Protein intake (dietary record) baseline. [ Time Frame: To evaluate the food consumption will be used the dietary record of three days. ]
2. Protein intake (24-hour food recall). [ Time Frame: To verify possible changes in dietary intake over the 12 weeks of intervention, a 24-hour food recall will be applied on the fourth and eighth week and immediately after the last training session. ]
3. Diet Quality Index. [ Time Frame: To evaluate the quality of the diet will be used the Healthy Eating Index (HEI) that assigns scores to the diet according to the adequacy of the food and nutrients intake, based on the 24 hour reminders previously applied. ]
4. Quality of life (SF-36) change from baseline. [ Time Frame: This measure will be performed before and after the intervention (12-week resistance training and supplementation). The SF-36 (Medical Outcomes Study 36) questionnaire will be used to evaluate the quality of life of the elderly. ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Be 60 or older, and in the case of women, they must be postmenopausal (interruption of menstruation for more than one year).
• Have not participated in any systematic exercise program for at least six months prior to the start of this project.
• To have a body mass index (BMI) between 22 and 30 kg / m2.
• Are not cardiopathic, diabetic or have any other metabolic disease.
• Do not present joint problems or any other injury that prevents the proper execution of the exercises of the training routine.
• Non-smoker or have quit smoking for at least five years ago.
• Release of the doctor (medical certificate) to perform the physical exercises.

Exclusion Criteria:

• Do not participate in at least 20 training sessions or miss more than three consecutive training sessions.

Contacts and Locations

Locations

Brazil

Federal University of Health Sciences

Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

More Information

• Responsible Party: Cláudia Dornelles Schneider, Principal Investigator, Federal University of Health Science of Porto Alegre
• ClinicalTrials.gov Identifier: NCT03862937
• Other Study ID Numbers: FUHSPortoAlegre2019
• First Posted: March 5, 2019
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cláudia Dornelles Schneider, Federal University of Health Science of Porto Alegre:

Protein Supplementation; Body Composition; Resistance Training; Functional Capacity; Muscle Strength

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical