Menu
Recruiting NCT05862779

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

No phase Interventional Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo Group, Whey Protein + Placebo, Omega 3 + Placebo, Omega 3 + Whey Protein.
Who it may be relevant to
Registry conditions: Sarcopenia. Basic parameters: 60 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

Interventions

  • Dietary supplement Placebo Group
    The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin.
  • Dietary supplement Whey Protein + Placebo
    The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil.
  • 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.
  • 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.

Primary outcome measures

  • Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women [Time frame: up to 12 weeks]
Secondary outcome measures (1)
  • Changes in strength (kg) using dynamometer in postmenopausal women [Time frame: up to 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Brazil · 1 center
  • Federal University of Uberlandia — Uberlândia

Identifiers

NCT: NCT05862779 · 5.728.049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗