Beetroot Juice for Boosting Immunity During a Time of Stress.

NCT06434181 | Completed Phase 2

• 1 other identifier: 1866308
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the present study is to explore the effects of a dietary nitrate supplement (i.e., beetroot juice) on nitric oxide levels, immunity, mood, and cardiovascular activity during and following final exam stress in healthy individuals.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Wisconsin Upper Respiratory Symptom Survey (WURSS)

  Assesses symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire

  Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations)

• Changes in IL-8 levels

  Change in IL-8 levels

  Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

Secondary Outcomes (6)

• Resting blood pressure

  Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

• Acute stress

  Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

• Change in negative affect

  Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

• Adherence monitoring (feasibility )

  Every day, twice a day during active beetroot

• Exhaled Nitric Oxide

  Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

Study Arms (2)

Beetroot Juice

EXPERIMENTAL

Participants in this group are given 7 daily doses of a dietary nitrate supplement (Beet-it Sport beetroot juice shots, ) and asked to drink two doses daily during the week of their final academic examinations of that term in college.

Dietary Supplement: Beetroot Juice

Placebo Control

PLACEBO COMPARATOR

Participants in this group are given 7 daily doses of a placebo matched in appearance and taste (Beet-it Sport placebo juice shots) and asked to drink two doses daily during the week of their final academic examinations of that term in college.

Dietary Supplement: Placebo Control

Interventions

Beetroot Juice DIETARY_SUPPLEMENT

Beet-It Sports Shot, 70mL, containing 6.5 mmol nitric oxide (taking two shots per day in active group)

Beetroot Juice

Placebo Control DIETARY_SUPPLEMENT

Beet-It Placebo Shot, 70mL (taking two shots per day in placebo group)

Placebo Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently enrolled at Baylor University or Southern Methodist University

You may not qualify if:

• Current smoker
• Clinically significant asthma, COPD, Emphysema, heart disease, cerebrovascular disease, thyroid dysfunction, out of control diabetes
• Pregnancy, diagnosis of schizophrenia, psychosis, mood disorder, psychosis, drug or alcohol dependance

Sponsors & Collaborators

• Baylor University: lead
• Southern Methodist University: collaborator

Study Sites (2)

Southern Methodist University

Dallas, Texas, 75205, United States

Location

Annie T. Ginty

Waco, Texas, 76798, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The lead researcher, data collectors, and participants were blinded to the conditions. The distribution of the supplements for each condition was performed by a member of the staff that was not involved with the study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: April 11, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

US (2)