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

Sponsor
Federal University of Uberlandia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862779
Collaborator
(none)
80
4
18.1

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo Group
  • Dietary Supplement: Whey Protein + Placebo
  • Dietary Supplement: Omega 3 + Placebo
  • Dietary Supplement: Omega 3 + Whey Protein
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women [up to 12 weeks]

Secondary Outcome Measures

  1. Changes in strength (kg) using dynamometer in postmenopausal women [up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Federal University of Uberlandia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erick Prado de Oliveira, Assistant professor, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT05862779
Other Study ID Numbers:
  • 5.728.049
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023