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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04282265
Other study ID # 050719
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2019
Est. completion date November 29, 2019

Study information

Verified date February 2020
Source Lipscomb University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The investigators aim to measure muscle strength, athletic performance, body composition, and muscle size in two groups of adults before and after 11 weeks of intervention in a randomized, double blinded study. One group (n=15 ) will receive an intervention of resistance exercise and a Red Spinach Extract supplement, and the other group (n=15) will receive resistance exercise and a placebo (maltodextrin).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 29, 2019
Est. primary completion date November 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 34 Years
Eligibility Inclusion Criteria:

- 18-35 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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo
Oral placebo capsules will be taken consisting of maltodrextrin daily for 11 weeks
Red Spinach Extract (RSE)
Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 11 weeks

Locations

Country Name City State
United States Jeremy Townsend Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Lipscomb University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscular Strength Muscular strength will be assessed via bench press 1-repetition maximum 11 weeks
Primary Muscular Hypertrophy Muscle thickness of the Rectus femoris and vastus lateralis will be assessed via ultrasonography. Thickeness will be reported in cm. 11 weeks
Primary Body Composition Lean Body Mass, Fat Mass, and Bone Mineral Content will be assessed via Dual X-ray absorptiometry (DXA) 11 weeks
Primary 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
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