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Completed

NCT Number: NCT06412302

High Protein Dairy Products and Resistance Exercise 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.

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Key information

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Health and Performance Center

Santiago, Chile

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: WP

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.

Other names: PY

Primary outcomes

  1. 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

  2. Blood Lipids

    Time frame: From Baseline, up to 56 days

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

  3. Muscle Strength

    Time frame: From Baseline, up to 56 days

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

  4. Handgrip

    Time frame: From Baseline, up to 56 days

    Handgrip Strength measured on left and right hand (kg)

  5. Time Up and Go

    Time frame: From Baseline, up to 56 days

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

  6. Isokinetic Muscle Strength

    Time frame: From Baseline, up to 56 days

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

  7. 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

  8. Resting Metabolic Rate

    Time frame: From Baseline, up to 56 days

    Determine by indirect calorimetry (kcal/d)

  9. 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.

Secondary outcomes

  1. Food Consumption

    Time frame: From Baseline, up to 56 days

    24h food recall

  2. 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).

Sponsors and collaborators

Lead sponsor

Universidad de O´Higgins

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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