Clinical trial NCT06412302: High Protein Dairy Products and Resistance Exercise in the Elderly
Official title: No-Whey: High Protein Dairy and Resistance Exercise for the Improvement of Body Composition and Muscle Function in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dairy Products
Whey Protein
Resistance Training
Older Adults
Lead sponsor: Universidad de O´Higgins
Sponsor class: OTHER
Collaborators: name: Instituto de Nutrición y Tecnología de los Alimentos
name: Geroscience Center for Brain Health and Metabolism (Gero)
name: Motion Health and Performance Center
First posted: 2024-05-14
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body Composition
timeFrame: From Baseline, up to 56 days
measure: Blood Lipids
timeFrame: From Baseline, up to 56 days
measure: Muscle Strength
timeFrame: From Baseline, up to 56 days
measure: Handgrip
timeFrame: From Baseline, up to 56 days
measure: Time Up and Go
timeFrame: From Baseline, up to 56 days
measure: Isokinetic Muscle Strength
timeFrame: From Baseline, up to 56 days
measure: Aerobic Capacity
timeFrame: From Baseline, up to 56 days
measure: Resting Metabolic Rate
timeFrame: From Baseline, up to 56 days
measure: Evaluation of the intestinal microbiota
timeFrame: From Baseline, up to 56 days
Secondary outcomes:
measure: Food Consumption
timeFrame: From Baseline, up to 56 days
measure: Evaluation of liver characteristics profile
timeFrame: From Baseline, up to 56 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Motion Health and Performance Center
Study officials:
References: