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NCT Number: NCT05862779

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

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

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-902, Brazil

Location status: Recruiting

Location contact

Erick P de Oliveira, PhD

CONTACT

[email protected]

14997273137

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Placebo Group

Dietary Supplement

The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin.

Whey Protein + Placebo

Dietary Supplement

The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil.

Omega 3 + Placebo

Dietary Supplement

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

Dietary Supplement

The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein.

Primary outcomes

  1. Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women

    Time frame: up to 12 weeks

Secondary outcomes

  1. Changes in strength (kg) using dynamometer in postmenopausal women

    Time frame: up to 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Erick P de Oliveira, PhD

CONTACT

[email protected]

+5534 3225-8584

Erick P de Oliveira, PhD

CONTACT

[email protected]

+5514997273137

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study 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

Acronym: W-3 and Whey

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 17, 2023
Registry last updated
Oct 16, 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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