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

NCT ID: NCT05862779

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2026-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Whey Protein + Placebo

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Omega 3 + Placebo

Intervention Type 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

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.

Group Type EXPERIMENTAL

Omega 3 + Whey Protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo Group

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

Intervention Type DIETARY_SUPPLEMENT

Whey Protein + Placebo

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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Erick Prado de Oliveira

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Erick P de Oliveira, PhD

Role: CONTACT

+5534 3225-8584

Erick P de Oliveira, PhD

Role: CONTACT

+5514997273137

Facility Contacts

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Erick P de Oliveira, PhD

Role: primary

14997273137

Other Identifiers

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5.728.049

Identifier Type: -

Identifier Source: org_study_id

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