The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers

NCT06462898 | Recruiting

• 1 other identifier: USUHS.2023-118
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to test the effect of omega-3 on physical performance and recovery of Soldiers. Objectives 1: Assess the impact of 8-weeks of daily consumption of 1600mg of omega-3 fortified smoothie on O3I response. Objective 2: Determine the relationship between O3I and measures of performance and recovery. Participants will:

• Be randomly assigned to placebo group or to the omega-3 fortified smoothie group.
• The intervention group will take omega-3 fortified smoothies and controls will consume a non-fortified smoothie, five days a week for 8 weeks.
• Participate in Army Combat Fitness Tests (ACFT)
• Complete surveys that assess dietary intake, physical activity (PAQ) and sleep quality (PSQI).
• Complete a finger prick to determine omega-3 index. Assessments will be collected pre/post intervention. Researchers will compare intervention and placebo groups to see if omega-3 levels increase, and improve physical performance and recovery.

Conditions

Nutrition, Healthy

Keywords

Omega-3 fatty acids; Holistic Health and Fitness (H2F); Army Combat Fitness Test (ACFT); Performance; Nutrition; Recovery

Outcome Measures

Primary Outcomes (2)

• Omega-3 Index

  Omega-3 Index will be measured through finger prick, obtaining 1-2 drops of blood on a collection card to be sent to OmegaQuant for analysis. A score of 8-12% is desirable, 4-7.9% is moderate and \< 4% is low.

  Week 1 and Week 8

• Army Combat Fitness Test (ACFT)

  ACFT test will be performed at Week 1 baseline and Week 8 post-intervention to show changes in physical performance.

  Week 1 and Week 8

Study Arms (2)

Omega-3 Fortified Protein Smoothie

ACTIVE COMPARATOR

Participants will receive a shaker bottle containing 1 tbsp omega-3 powder and 1 scoop protein powder mixed with water, after morning physical training, five days a week, for eight weeks.

Dietary Supplement: Omega-3 Fortified Protein Smoothie

Non-Fortified Protein Smoothie

PLACEBO COMPARATOR

Participants will receive a shaker bottle containing 1 scoop protein mixed with water, after morning physical training, five days a week, for eight weeks.

Dietary Supplement: Non-Fortified Protein Smoothie

Interventions

Omega-3 Fortified Protein Smoothie DIETARY_SUPPLEMENT

Omega-3 powder and protein supplementation.

Omega-3 Fortified Protein Smoothie

Non-Fortified Protein Smoothie DIETARY_SUPPLEMENT

Protein without omega-3 powder supplementation.

Non-Fortified Protein Smoothie

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Active Duty Military Personnel
• Current soldier at Ft. Drum or Ft. Campbell.
• Able and willing to complete two Army Combat Fitness Test (ACFT) (Week 1 and week 8)
• Willing to obtain two finger pricks for the Omega-3 Index (week 1 and week 8)

You may not qualify if:

• Allergic to fish

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (2)

Fort Campbell

Fort Campbell North, Kentucky, 42223, United States

ACTIVE NOT RECRUITING

Fort Drum

Fort Drum, New York, 13602, United States

RECRUITING

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Study Officials

• Melissa Rittenhouse, PhD

  Uniformed Services University Health Sciences/Henry M. Jackson Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Rittenhouse, PhD

CONTACT

301-295-2621; melissa.rittenhouse.ctr@usuhs.edu

Saachi Khurana, BS

CONTACT

703-220-7927; saachi.khurana.ctr@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded. The research team will pre-mix the drinks and have them labeled for participants daily. Both drinks look and taste the same.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist/Exercise Scientist

Model Details: A blinded randomized-placebo control trial will be conducted in collaboration with the Army Holistic Health and Fitness (H2F) Program. Participants will be randomly selected from two H2F training sites: Ft. Campbell and Ft. Drum. In total, 100 participants will be randomly selected. Each site will have participants assigned to the placebo group and omega-3 enhanced smoothie group. Participants will be excluded if they have a fish allergy or if they are unable to complete an Army Combat Fitness Test (ACFT) for any reason. Participants taking omega-3 supplements will not be excluded, but will be instructed to be consistent for the duration of the study.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 17, 2024
• Study Start: February 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)