Impact of Supplements on Stress Markers

NCT05592561 | Completed

• 1 other identifier: Supplements and VR-ASD
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine the effects of caffeine, theanine and tyrosine ingestion on markers of stress in healthy college aged individuals that are exposed to a mental stress task. The main questions to answer are:

1. 1.what is the impact of a mental stress task involving a cognitive challenge and virtual reality based active shooter scenario on markers of subjective and biological stress?
2. 2.what is the impact of supplement ingestion (caffeine, theanine, tyrosine, analyzed separately) 40 min prior to exposure to the mental stress task?

Conditions

Physiological Stress

Outcome Measures

Primary Outcomes (5)

• salivary secretory IgA

  SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress

  Up to 10 months

• salivary alpha amylase

  salivary alpha amylase is an enzyme involved in digestive processes. amylase concentrations in saliva have been shown to reflect sympathetic stress. Thus, as sympathetic stress increases, salivary alpha amylase concentrations tend to increase

  Up to 10 months

• salivary cortisol

  salivary cortisol is a marker of stress which reflects activation of the hypothalamic pituitary adrenal axis.

  Up to 10 months

• heart rate

  heart rate reflects activity from the parasympathetic and sympathetic nervous system and increases when exposed to stress

  Up to 10 months

• State anxiety inventory

  state anxiety inventory is a subjective scale which includes six short statements such as "I feel calm" or " I feel tense" and composite scores of participant responses are used for analysis. Higher values reflect higher subjective anxiety.

  Up to 10 months

Secondary Outcomes (6)

• mental arithmetic incorrect

  Up to 10 months

• mental arithmetic missed responses

  Up to 10 months

• mental arithmetic response time

  Up to 10 months

• Stroop challenge number of incorrect

  Up to 10 months

• Stroop challenge number of missed responses

  Up to 10 months

Study Arms (4)

Caffeine group

EXPERIMENTAL

Subjects will receive 200 mg of caffeine powder which was obtained from a 200 mg capsule (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada). Researchers will break open the capsule and mix with water and 5/8 tsp of crystal light immediately before subjects ingest the randomly assigned treatment.

Other: mental stress task

Placebo

PLACEBO COMPARATOR

flavored water (sweetened with crystal light powder, 0.5 tsp) will be provided to subjects without any caffeine powder added.

Other: mental stress task

Theanine group

EXPERIMENTAL

200mg pure theanine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) + 8 oz water+ 0.55 tsp crystal light will be ingested.

Other: mental stress task

Tyrosine group

EXPERIMENTAL

2000 mg pure tyrosine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) +8 oz water + 0.5 tsp crystal light will be ingested.

Other: mental stress task

Interventions

mental stress task OTHER

The stress protocol used for this experiment utilized a cognitive challenge and a previously studied virtual reality active shooter drill (VR-ASD). The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). Immediately upon completion of the cognitive challenge, the subjects completed the VR-ASD scenario (\~2 min) followed by the same cognitive challenge with different questions (another 4 min). The total duration was \~10 min.

Caffeine group; Placebo; Theanine group; Tyrosine group

Eligibility Criteria

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

You may qualify if:

• apparently healthy, aged 18-40,
• free from any known cardiovascular or metabolic diseases,
• free from any major stressors within the last 30 days such as birth of a child, abortion, or divorce.

You may not qualify if:

• subjects are required to not have a history of motion sickness or vertigo,
• not previously diagnosed with a brain injury or epilepsy.

Sponsors & Collaborators

• Texas State University: lead
• M. Hunter Martaindale: collaborator
• C. Dillard: collaborator
• D. Gonzalez: collaborator

Study Sites (1)

Texas State University

San Marcos, Texas, 78666, United States

Location

Related Publications (2)

• McAllister MJ, Martaindale MH, Dillard CC, McCullough R. Impact of L-theanine and L-tyrosine on markers of stress and cognitive performance in response to a virtual reality based active shooter training drill. Stress. 2024 Jan;27(1):2375588. doi: 10.1080/10253890.2024.2375588. Epub 2024 Jul 8.

  PMID: 38975711 DERIVED

• McAllister MJ, Martaindale MH, Dillard CC, Gonzalez DE. Stress response to virtual reality based active shooter training: Impact of caffeine consumption. Psychoneuroendocrinology. 2024 Mar;161:106923. doi: 10.1016/j.psyneuen.2023.106923. Epub 2023 Dec 7.

  PMID: 38142605 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The researchers will prepare the caffeine, placebo, tyrosine, and theanine containing sweetened and flavor matched beverages immediately before subjects ingested them. The subjects will not be told which treatment they will be receiving. There will be no indicative labels on the water bottle provided to them which contained the crystal light which will be mixed with either 200 mg of caffeine, 200 mg of theanine, 2000 mg tyrosine or crystal light only (placebo)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be randomly assigned to one of four treatments: 1. placebo ingestion 2. caffeine ingestion 3. theanine ingestion 4. tyrosine ingestion nutrient ingestion takes place 40 min prior to being exposed to a mental stress task.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: January 25, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (1)