Effects of Omega-3 and Whey Protein Supplementation on Lean Mass in Older Adults

Sarcopenia Clinical Trial

Official title:

Effects of Omega-3 and Whey Protein Supplementation on Lean Mass and Strength Gains in Older Adults Performing Resistance Exercise: A Randomized, Double-Blind and Placebo-Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05862779
• Other study ID #: 5.728.049
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: Federal University of Uberlandia
• Contact: Erick P de Oliveira, PhD
• Phone: +5534 3225-8584
• Email: erick_po[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of omega-3 supplementation combined with whey protein intake on lean mass and strength gains in older adults performing resistance exercise. Participants will be randomized into the 4 groups. The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin. The omega 3 + placebo group will receive 4 g per day of fish oil and 40 g per day of maltodextrin. The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil. The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein. All will perform the same exercise protocol for 12 weeks

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women (at least 1 year of menstrual interruption, self-reported);

• To be able to practice strength exercises;

• To be able to carry out supplementation;

• Do not present physical, orthopedic or cardiovascular complications that prevent the performance of physical exercises;

• No history of stroke or acute myocardial infarction;

• Not being a smoker and/or alcoholic;

• Do not perform hormone replacement therapy;

• Do not use anti-inflammatory drugs;

• To have normal kidney function;

• To submit a medical certificate of health that proves that the individual is able to perform exercises.

Exclusion Criteria:

• Do not provide the necessary information for the development of the study;

• Individuals with diseases previously diagnosed and undergoing treatment, such as type II diabetes mellitus, cancer, rheumatoid arthritis, high blood pressure, dyslipidemia, cardiovascular, and kidney and/or liver diseases.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Placebo Group
The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin.
• Whey Protein + Placebo
The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil.
• Omega 3 + Placebo
The omega 3 + placebo group will receive 4 g per day of fish oil and 40 g per day of maltodextrin.
• Omega 3 + Whey Protein
The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women		up to 12 weeks
Secondary	Changes in strength (kg) using dynamometer in postmenopausal women		up to 12 weeks