High Protein Dairy Products and Resistance Exercise in the Elderly

NCT06412302 | Completed DMC

• 1 other identifier: 027-2023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dairy Products; Whey Protein; Resistance Training; Older Adults

Outcome Measures

Primary Outcomes (9)

• Body Composition

  Changes in weight, total fat mass, total skeletal muscle mass, segmental fat and muscle mass

  From Baseline, up to 56 days

• Blood Lipids

  Changes on Serum Triglycerides, Total Cholesterol, and High Density Cholesterol (mmol/L)

  From Baseline, up to 56 days

• Muscle Strength

  Determine by Isometric mid-tight pull (Newton, N)

  From Baseline, up to 56 days

• Handgrip

  Handgrip Strength measured on left and right hand (kg)

  From Baseline, up to 56 days

• Time Up and Go

  Length of time from sitting-walk-sit (seconds)

  From Baseline, up to 56 days

• Isokinetic Muscle Strength

  Maximal peak torque from left and right quadriceps and hamstrings (N/m)

  From Baseline, up to 56 days

• Aerobic Capacity

  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

  Determine by indirect calorimetry (kcal/d)

  From Baseline, up to 56 days

• Evaluation of the intestinal microbiota

  Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.

  From Baseline, up to 56 days

Secondary Outcomes (2)

• Food Consumption

  From Baseline, up to 56 days

• Evaluation of liver characteristics profile

  From Baseline, up to 56 days

Study Arms (2)

Whey Protein+Resistance Training

EXPERIMENTAL

Participants will undergo 8 weeks of resistance training and receive a whey protein shake after each exercise session.

Other: Whey Protein+Resistance Training

Protein Yogurt+Resistance Training

EXPERIMENTAL

Participants will undergo 8 weeks of resistance training and receive a yogurt shake after each exercise session.

Other: High protein yogurt+Resistance Training

Interventions

Whey Protein+Resistance Training OTHER

WP group received 25g protein on one scoop of Whey Protein Isolate (Iso100 Dymatize) with 8 weeks of resistance training 3 days a week.

Also known as: WP

Whey Protein+Resistance Training

High protein yogurt+Resistance Training OTHER

PY group received 24.6g protein on two High Protein yogurts (Lonco Leche) with 8 weeks of resistance training 3 days a week.

Also known as: PY

Protein Yogurt+Resistance Training

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de O´Higgins: lead
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator
• Geroscience Center for Brain Health and Metabolism (Gero): collaborator
• Motion Health and Performance Center: collaborator

Study Sites (1)

Motion Health and Performance Center

Santiago, Chile

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The PY group will be provided with two yogurts and 50 of water (220g per serving, containing 24.6g protein, 1.4g fat, and 16.6 carbohydrates), while the WP will be provided with a shake with water (25g per serving containing; 25g protein, 0g fat, and 1g carbohydrates, dissolved in water), immediately after the exercise session which a trainer will monitor. Both groups will submit to a resistance training group every 8 weeks.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2023
• Primary Completion: September 25, 2023
• Study Completion: January 12, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CL (1)