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

NCT05862779 | Recruiting

• 1 other identifier: 5.728.049
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

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

  up to 12 weeks

Secondary Outcomes (1)

• Changes in strength (kg) using dynamometer in postmenopausal women

  up to 12 weeks

Study Arms (4)

Placebo Group

PLACEBO COMPARATOR

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

Whey Protein + Placebo

EXPERIMENTAL

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

Omega 3 + Placebo

EXPERIMENTAL

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

Omega 3 + Whey Protein

EXPERIMENTAL

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

Interventions

Placebo Group DIETARY_SUPPLEMENT

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

Placebo Group

Whey Protein + Placebo DIETARY_SUPPLEMENT

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

Whey Protein + Placebo

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 + Placebo

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.

Omega 3 + Whey Protein

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-902, Brazil

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Whey Proteins; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Erick P de Oliveira, PhD

CONTACT

+5534 3225-8584; erick_po@yahoo.com.br

Erick P de Oliveira, PhD

CONTACT

+5514997273137; erick_po@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 17, 2023
• Study Start: July 30, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)