NCT04282265

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 . In recent research, Red spinach extract has been shown to be beneficial in acute exercise performance. However, currently it is unclear how these acute increases in performance may translate to long term training adaptations. This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical performance, body composition, and health following chronic resistance training and anaerobic exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

August 23, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

January 16, 2020

Last Update Submit

February 21, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Muscular Strength

    Muscular strength will be assessed via bench press 1-repetition maximum

    11 weeks

  • Muscular Hypertrophy

    Muscle thickness of the Rectus femoris and vastus lateralis will be assessed via ultrasonography. Thickeness will be reported in cm.

    11 weeks

  • Body Composition

    Lean Body Mass, Fat Mass, and Bone Mineral Content will be assessed via Dual X-ray absorptiometry (DXA)

    11 weeks

  • Wingate Anaerobic (WnT) Cycle test performance

    A 30-second WnT test will be used to assess Average power, peak power, and fatiuge index

    11 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Red Spinach Extract

EXPERIMENTAL
Dietary Supplement: Red Spinach Extract (RSE)

Interventions

PlaceboDIETARY_SUPPLEMENT

Oral placebo capsules will be taken consisting of maltodrextrin daily for 11 weeks

Placebo
Red Spinach Extract (RSE)DIETARY_SUPPLEMENT

Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 11 weeks

Red Spinach Extract

Eligibility Criteria

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

You may qualify if:

  • years old
  • At least 1 year of resistance training experience
  • Are free of musculoskeletal injuries
  • Are not taking medications that may interfere with study measurements

You may not qualify if:

  • Participant 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 Design

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

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 24, 2020

Study Start

August 23, 2019

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations