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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Placebo Group; Dietary supplement: Whey Protein + Placebo; Dietary supplement: Omega 3 + Placebo; Dietary supplement: Omega 3 + Whey Protein

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erick P de Oliveira, PhD; Phone Number: +5534 3225-8584; Email: erick_po@yahoo.com.br
• Study Contact Backup: Name: Erick P de Oliveira, PhD; Phone Number: +5514997273137; Email: erick_po@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Group supplemented with maltodextrin (40g/day) and corn oil (4g/day). All groups will undergo a training program with strength exercises for 12 weeks	Dietary supplement: Placebo Group; The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin.
Experimental: Whey Protein + Placebo; Group supplemented with isolated whey protein (40g/day) and corn oil (4g/day). All groups will undergo a training program with strength exercises for 12 weeks.	Dietary supplement: Whey Protein + Placebo; The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil.
Experimental: Omega 3 + Placebo; Group supplemented with omega-3 (4g/day) and maltodextrin (40g/day). All groups will undergo a training program with strength exercises for 12 weeks.	Dietary supplement: Omega 3 + Placebo; The omega 3 + placebo group will receive 4 g per day of fish oil and 40 g per day of maltodextrin.
Experimental: Omega 3 + Whey Protein; Group supplemented with omega-3 (4g/day) and whey protein (40g/day). All groups will undergo a training program with strength exercises for 12 weeks.	Dietary supplement: Omega 3 + Whey Protein; The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in strength (kg) using dynamometer in postmenopausal women	up to 12 weeks

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 5.728.049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No