NCT06364254

Brief Summary

Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

March 8, 2024

Last Update Submit

May 31, 2024

Conditions

Healthy

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (5)

  • Difference in Time Trial Times

    Time to run 2 miles on an indoor treadmill

    10-25 minutes

  • Difference in Anxiety Measured with the State Trait Anxiety Inventory

    This questionnaire will be administered just before each run to assess the individual's current anxiety symptoms.The State-Trait Anxiety Inventory (STAI) consists of 20 items aimed at evaluating trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Not at all" to "Very much so"). Higher scores suggest elevated anxiety.

    5 minutes

  • Difference in Blood Lactate Concentrations

    Blood lactate will be measured just before the time trial, 3 minutes after the start of the run, after 1 mile and 1.98 miles of running and after 5, 10, 15, and 30 minutes of walking recovery. Higher lactate concentrations are associated with more effort during exercise and a slower recovery from exercise.

    45 minutes

  • Difference in Gastrointestinal Distress

    This questionnaire consists of 12 questions related to distress symptoms. Responses are absent, mild, moderate, severe. The higher the score, the more GI distress is present. This assessment will be completed after the 2 mile run.

    5 minutes

  • Different in Heart Rate Variability

    The root mean square successive difference method will be used with the 10 second electrocardiogram reading. Higher heart rate variability is associated with better health.

    5 minutes

Study Arms (2)

Cannabidiol

EXPERIMENTAL

Cannabidiol capsules 2 hours prior to 2 mile run.

Dietary Supplement: Cannabidiol Capsules

Placebo

PLACEBO COMPARATOR

Placebo capsules 2 hours prior to 2 mile run.

Dietary Supplement: Cannabidiol Capsules

Interventions

Cannabidiol CapsulesDIETARY_SUPPLEMENT

300 mg of cannabidiol administered 2 hours before 2 mile run

CannabidiolPlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals identifying as female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Running at least 2 miles 2 times per week.

You may not qualify if:

  • Current diagnosis of a chronic disease or serious mental health disorder.
  • Current or use of cannabis or cannabis products within the past 4 weeks
  • Currently in perimenopause or menopause, transgender female not undergoing hormone treatment (estrogen)
  • Having any underlying health concerns or have any current injuries that can be worsened with exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Northern Colorado

Greeley, Colorado, 80639, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2024

First Posted

April 15, 2024

Study Start

November 11, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

US(1)