High Protein Dairy Products and Resistance Exercise in the Elderly

May 8, 2024 updated by: Matias Monsalves Álvarez, Universidad de O´Higgins

No-Whey: High Protein Dairy and Resistance Exercise for the Improvement of Body Composition and Muscle Function in the Elderly

Protein supplementation is one of the main recommendations for regular endurance physical exercise (RT). In older people, the need for protein increases particularly in the face of physiological and pathophysiological changes associated with the loss of muscle tissue and function, so protein intake becomes more relevant in this population. Fermented dairy products such as yogurt, and especially those with an extra protein content, have increased their popularity and consumption in the national market. Their nutritional composition is of particular interest, given their amino acid profile and in particular their high Leucine content, which could be compared with the classic protein supplements recommended for muscle gain and recovery. Objective: To analyze the effect on body composition, lipid profile, physical condition and muscle functionality induced by the intake of high protein yogurts versus Whey protein together with a muscular resistance program in elderly people. Hypothesis: The intake of high protein yogurts will lead to equal or greater gains in muscle mass, physical condition and functionality than those obtained with the intake of Whey protein together with resistance training in elderly people.Methodology: 16 healthy, lactose intolerant free, older (60-75 years old) subjects will be recruited to perform 8 weeks of muscular resistance training (RT) 3 times per week, who will be randomly supplemented with high protein yogurt (PY) or Whey protein (WP). At baseline and at the end of the intervention, body composition will be assessed by DEXA, muscle strength, maximal oxygen consumption and lipid profile. Expected Results: The YPRT group is expected to achieve similar or greater increases in muscle strength, fat-free mass, lipid profile and decrease in fat mass than the WP group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Motion Health and Performance Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • >60 years
  • Less than 1 hour of exercise a week

Exclusion Criteria:

  • Lactose Intolerant
  • Smoking
  • Type 1 or 2 Diabetes
  • Alcohol intake
  • Currently taking protein, high protein yogurts, creatine, HMB or any other supplement that aims to improve muscle mass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whey Protein+Resistance Training
Participants will undergo 8 weeks of resistance training and receive a whey protein shake after each exercise session.
Other: Whey Protein+Resistance Training
WP group received 25g protein on one scoop of Whey Protein Isolate (Iso100 Dymatize) with 8 weeks of resistance training 3 days a week.
Other Names:
  • WP
Experimental: Protein Yogurt+Resistance Training
Participants will undergo 8 weeks of resistance training and receive a yogurt shake after each exercise session.
Other: High protein yogurt+Resistance Training
PY group received 24.6g protein on two High Protein yogurts (Lonco Leche) with 8 weeks of resistance training 3 days a week.
Other Names:
  • PY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: From Baseline, up to 56 days
Changes in weight, total fat mass, total skeletal muscle mass, segmental fat and muscle mass
From Baseline, up to 56 days
Blood Lipids
Time Frame: From Baseline, up to 56 days
Changes on Serum Triglycerides, Total Cholesterol, and High Density Cholesterol (mmol/L)
From Baseline, up to 56 days
Muscle Strength
Time Frame: From Baseline, up to 56 days
Determine by Isometric mid-tight pull (Newton, N)
From Baseline, up to 56 days
Handgrip
Time Frame: From Baseline, up to 56 days
Handgrip Strength measured on left and right hand (kg)
From Baseline, up to 56 days
Time Up and Go
Time Frame: From Baseline, up to 56 days
Length of time from sitting-walk-sit (seconds)
From Baseline, up to 56 days
Isokinetic Muscle Strength
Time Frame: From Baseline, up to 56 days
Maximal peak torque from left and right quadriceps and hamstrings (N/m)
From Baseline, up to 56 days
Aerobic Capacity
Time Frame: From Baseline, up to 56 days
Maximal Oxygen Consumption determine by the volume of oxygen (L/min)obtained on a incremental test
From Baseline, up to 56 days
Resting Metabolic Rate
Time Frame: From Baseline, up to 56 days
Determine by indirect calorimetry (kcal/d)
From Baseline, up to 56 days
Evaluation of the intestinal microbiota
Time Frame: From Baseline, up to 56 days
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
From Baseline, up to 56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Consumption
Time Frame: From Baseline, up to 56 days
24h food recall
From Baseline, up to 56 days
Evaluation of liver characteristics profile
Time Frame: From Baseline, up to 56 days
Uric acid, BUN, Albumin, Creatinine aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L).
From Baseline, up to 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de O´Higgins

Collaborators

Instituto de Nutrición y Tecnología de los Alimentos
Geroscience Center for Brain Health and Metabolism (Gero)
Motion Health and Performance Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

September 25, 2023

Study Completion (Actual)

January 12, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 027-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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