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

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo Group
Whey Protein + Placebo
Omega 3 + Placebo
Omega 3 + Whey Protein
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo Group

    Whey Protein + Placebo

    Omega 3 + Placebo

    Omega 3 + Whey Protein

    Arm Description

    Group supplemented with maltodextrin (40g/day) and corn oil (4g/day). All groups will undergo a training program with strength exercises for 12 weeks

    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.

    Group supplemented with omega-3 (4g/day) and maltodextrin (40g/day). All groups will undergo a training program with strength exercises for 12 weeks.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Changes in strength (kg) using dynamometer in postmenopausal women

    Full Information

    First Posted
    April 10, 2023
    Last Updated
    May 8, 2023
    Sponsor
    Federal University of Uberlandia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05862779
    Brief Title
    Effects of Omega-3 and Whey Protein Supplementation on Lean Mass in Older Adults
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Uberlandia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Group supplemented with maltodextrin (40g/day) and corn oil (4g/day). All groups will undergo a training program with strength exercises for 12 weeks
    Arm Title
    Whey Protein + Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Omega 3 + Placebo
    Arm Type
    Experimental
    Arm Description
    Group supplemented with omega-3 (4g/day) and maltodextrin (40g/day). All groups will undergo a training program with strength exercises for 12 weeks.
    Arm Title
    Omega 3 + Whey Protein
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Group
    Intervention Description
    The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Whey Protein + Placebo
    Intervention Description
    The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega 3 + Placebo
    Intervention Description
    The omega 3 + placebo group will receive 4 g per day of fish oil and 40 g per day of maltodextrin.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega 3 + Whey Protein
    Intervention Description
    The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein.
    Primary Outcome Measure Information:
    Title
    Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in strength (kg) using dynamometer in postmenopausal women
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Erick P de Oliveira, PhD
    Phone
    +5534 3225-8584
    Email
    erick_po@yahoo.com.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Erick P de Oliveira, PhD
    Phone
    +5514997273137
    Email
    erick_po@yahoo.com.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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