Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

July 2, 2024 updated by: Christopher Bell
While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. We hope to learn if CBD can improve glucose tolerance and the gut microbiota, and if these two improvements might be related.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

More than 122 million Americans have diabetes, or its precursor, pre-diabetes. The clinical and public health implications are not trivial as diabetes is the leading cause of blindness and non-traumatic amputation; it is closely associated with vascular disease and premature death, and people with diabetes are at greater risk of serious and fatal complications associated with Covid-19. The defining feature of diabetes is dysfunctional regulation of blood glucose (blood sugar). Although numerous factors contribute to the development of type 2 diabetes, the gut microbiota has recently emerged as an important regulator of glucose homeostasis. Imbalances in the microbiota can lead to intestinal inflammation and loss of gut barrier integrity, which in turn activates inflammatory cascades outside of the gut that can precipitate development of metabolic dysfunction. Changes in the gut microbiota can also alter proportions of microbial metabolites such as secondary bile acids and short chain fatty acids, which have been shown to influence host metabolism. Diet is one of the most important modifiers of the gut microbiota and several plant-based chemicals have been shown to exert beneficial effects on its composition and function. Cannabis sativa L., which produces a suite of phytochemicals, referred to collectively as cannabinoids, has also been shown in epidemiologic studies to exert beneficial effects on glucose regulation. These effects may be, in part, due to interactions with the gut microbiota. The focus of this project is cannabidiol (often abbreviated as CBD). CBD is not marijuana. CBD is not cannabis. CBD is a bioactive phytochemical that is present in the plant Cannabis sativa; it has no psychoactive properties. Over recent years CBD has garnered considerable attention on account of its potential medicinal properties. There is increasing evidence that CBD may have therapeutic and/or preventative effects pertinent to cancer, cardiovascular disease, anxiety, and most relevant to the current proposal, diabetes and the gut microbiota. The aim of the proposed study is to evaluate the influence of short-term CBD on glucose tolerance and the gut microbiota. Hypothesis: compared with daily ingestion of a placebo, 4-weeks daily ingestion of CBD will improve glucose tolerance and favorably modify the gut microbiota towards a more anti-inflammatory profile.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523-1582
        • Colorado State University, Dept. of Health and Exercise Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age and older
  • Weight more than 110 pounds
  • Have a Body Mass Index greater than or equal to 25 kilograms/squared meters
  • Free of gastrointestinal or metabolic diseases
  • Sedentary (less than 150 minutes of moderate-intensity exercise per week during the previous 3 months)

Exclusion Criteria:

  • Less than 18 years of age
  • Pregnant or breastfeeding
  • Have known food allergies
  • Have been diagnosed with any autoimmune disorders or with compromised immune function
  • Celiac disease
  • Inflammatory bowel diseases
  • Gastrointestinal cancers
  • Diabetes
  • Human Immunodeficiency Virus
  • Adverse reaction to ingesting CBD oils, or CBD containing food products
  • Taking any of the following medications will be excluded as these may have negative interactions with CBD:
  • steroids,
  • 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors,
  • calcium channel blockers,
  • antihistamines,
  • human immunodeficiency virus antivirals
  • immune modulators,
  • benzodiazepines,
  • antiarrythmics,
  • antibiotics,
  • anesthetics,
  • antipsychotics,
  • antidepressants,
  • anti-epileptics,
  • beta blockers,
  • coumadin (warfarin),
  • proton pump inhibitors,
  • non-steroidal anti-inflammatory drugs,
  • angiotension II blockers,
  • oral hypoglycemic agents,
  • sulfonylureas.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dietary Supplement: Cannabidiol (CBD) powder formulation
T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate
Dietary supplement: Cannabidiol (CBD) powder formulation
30 mg CBD in the form of 300 mg of 10% CBD isolate
Other Names:
  • T-P-S-10 Caliper powder
Placebo Comparator: Dietary Supplement: CBD matching Placebo
Matching Placebo
Dietary supplement: Matching Placebo Cannabidiol (CBD) powder formulation
Matching Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Circulating blood glucose
Time Frame: Compared to baseline after 4 weeks of the intervention
Measurements of circulating blood glucose during an Oral Glucose Tolerance Tests via a blood analyzer
Compared to baseline after 4 weeks of the intervention
Circulating blood insulin
Time Frame: Compared to baseline after 4 weeks of the intervention
Measurements of circulating insulin during an Oral Glucose Tolerance Tests via a blood analyzer
Compared to baseline after 4 weeks of the intervention
Hepatic Insulin Extraction
Time Frame: Compared to baseline after 4 weeks of the intervention
Measurements of C-Peptide concentration via ELISA Assays
Compared to baseline after 4 weeks of the intervention
Tissue oxygenation
Time Frame: Compared to baseline after 4 weeks of the intervention
Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)
Compared to baseline after 4 weeks of the intervention
Reactive hyperemia
Time Frame: Compared to baseline after 4 weeks of the intervention
Measurement of reactive hyperemia via doppler ultrasound
Compared to baseline after 4 weeks of the intervention
Shannon and Faith's microbiota diversity scores in feces
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Compared to baseline after 4 weeks of the intervention
B-diversity scores for all fecal samples to assess clustering
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Compared to baseline after 4 weeks of the intervention
Differentially abundant microbiota in feces of collected during treatment
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Compared to baseline after 4 weeks of the intervention
Abundant microbiota to markers in feces
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via Linear discriminant analysis Effect Size algorithm
Compared to baseline after 4 weeks of the intervention
Human Granulocyte Macrophage Colony-Stimulating Factor
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interferon gamma
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 1 beta
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 2
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 4
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 5
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 6
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 7
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 8
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 10
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 12 (p70)
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Interleukin 13
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
Tumor Necrosis Factor alpha
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention
High-sensitivity C-reactive protein
Time Frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Compared to baseline after 4 weeks of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christopher Bell

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Caliper Foods

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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