High Protein Dairy Products and Resistance Exercise in the Elderly

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06412302
• Other study ID #: 027-2023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: May 2024
• Source: Universidad de O´Higgins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 12, 2024
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Older Adults
• Resistance Training

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Motion Health and Performance Center	Santiago

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de O´Higgins	Geroscience Center for Brain Health and Metabolism (Gero), Instituto de Nutrición y Tecnología de los Alimentos, Motion Health and Performance Center

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	Changes in weight, total fat mass, total skeletal muscle mass, segmental fat and muscle mass	From Baseline, up to 56 days
Primary	Blood Lipids	Changes on Serum Triglycerides, Total Cholesterol, and High Density Cholesterol (mmol/L)	From Baseline, up to 56 days
Primary	Muscle Strength	Determine by Isometric mid-tight pull (Newton, N)	From Baseline, up to 56 days
Primary	Handgrip	Handgrip Strength measured on left and right hand (kg)	From Baseline, up to 56 days
Primary	Time Up and Go	Length of time from sitting-walk-sit (seconds)	From Baseline, up to 56 days
Primary	Isokinetic Muscle Strength	Maximal peak torque from left and right quadriceps and hamstrings (N/m)	From Baseline, up to 56 days
Primary	Aerobic Capacity	Maximal Oxygen Consumption determine by the volume of oxygen (L/min)obtained on a incremental test	From Baseline, up to 56 days
Primary	Resting Metabolic Rate	Determine by indirect calorimetry (kcal/d)	From Baseline, up to 56 days
Primary	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	Food Consumption	24h food recall	From Baseline, up to 56 days
Secondary	Evaluation of liver characteristics profile	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