NCT04292106

Brief Summary

Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects. Red spinach extract has been shown to be beneficial in exercise performance, albeit mostly in aerobic exercise. In a previous study in our lab, we found that dietary nitrate consumption resulted in significantly greater isometric force production in teenage males. However, currently there is little know regarding the effects of dietary nitrate supplementation on isometric strength, resistance exercise and cognitive performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 17, 2020

Last Update Submit

January 13, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Bench Press Repetitions to Fatiuge

    Number of repetitions completed in each set during the acute exercise bout will be recorded and analyzed

    Through study completion, during both treatments (~4 weeks)

  • Bench Press Power

    Power during bench press repetitions will be measured via a linear transducer.

    Through study completion, during both treatments (~4 weeks)

  • Isometric Mid-thigh pull (IMTP) Peak Force

    Peak Force will be measured via dual force plates during a full-body isometric strength test.

    Through study completion, during both treatments (~4 weeks)

  • Isometric Mid-thigh pull (IMTP) Rate of Force Development

    Rate of Force development will be measured via dual force plates during a full-body isometric strength test.

    Through study completion, during both treatments (~4 weeks)

Secondary Outcomes (2)

  • Estimated Muscle Blood Flow via Near-infrared Spectroscopy (NIRS)

    Through study completion, during both treatments (~4 weeks)

  • Cognitive Performance via Stroop Test

    Through study completion, during both treatments (~4 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Red Spinach Extract (RSE)

EXPERIMENTAL
Dietary Supplement: Red Spinach Extract (RSE)

Interventions

Red Spinach Extract (RSE)DIETARY_SUPPLEMENT

Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 7 days

Red Spinach Extract (RSE)
PlaceboDIETARY_SUPPLEMENT

Oral placebo capsules will be taken consisting of maltodrextrin daily for 7 days

Placebo

Eligibility Criteria

Age18 Years - 34 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old Participants must have at least 1 year of resistance training experience.
  • Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
  • Are free of musculoskeletal injuries
  • Are not taking medications that may interfere with study measurements

You may not qualify if:

  • Participants that cannot take either the RSE or placebo supplement will be excluded, as this will be a double-blind study.
  • Furthermore, participants that cannot participate in pre- and post-research testing, and/or those that cannot commit to regular training sessions will be excluded.
  • Inability to perform physical exercise (determined by health and activity questionnaire)
  • Taking any other nutritional supplement or performance enhancing drug.
  • Any chronic illness that causes continuous medical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeremy Townsend

Nashville, Tennessee, 37215, United States

Location

Study Officials

  • Jeremy Townsend, PhD

    Lipscomb University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 17, 2020

First Posted

March 2, 2020

Study Start

September 26, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

January 14, 2022

Record last verified: 2022-01

Locations