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Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

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ClinicalTrials.gov Identifier: NCT05285449
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Collaborator:
Caliper Foods
Information provided by (Responsible Party):
Christopher Bell, Colorado State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Cannabidiol (CBD) powder formulation Dietary Supplement: Matching Placebo Cannabidiol (CBD) powder formulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind random assignment to either placebo or active CBD (2 x 30 mg daily)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The CBD and placebo formulations are prepared, bottled, and coded by Caliper Foods. The participants will receive a coded bottle to consume of the different formulations of CBD and placebo.
Primary Purpose: Basic Science
Official Title: Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
Actual Study Start Date : February 9, 2022
Estimated Primary Completion Date : March 9, 2023
Estimated Study Completion Date : March 9, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
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 Name: 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. Hepatic Insulin Extraction [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Measurements of C-Peptide concentration via ELISA Assays

  4. Tissue oxygenation [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)

  5. Reactive hyperemia [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Measurement of reactive hyperemia via doppler ultrasound

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Interferon gamma [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  12. Interleukin 1 beta [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  13. Interleukin 2 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  14. Interleukin 4 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  15. Interleukin 5 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  16. Interleukin 6 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  17. Interleukin 7 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  18. Interleukin 8 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  19. Interleukin 10 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  20. Interleukin 12 (p70) [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  21. Interleukin 13 [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  22. Tumor Necrosis Factor alpha [ Time Frame: Compared to baseline after 4 weeks of the intervention ]
    Assessed via 13-plex human T-cell cytokine panel

  23. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05285449


Contacts
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Contact: Christopher Bell, PhD 970-491-7522 Christopher.Bell@ColoState.EDU
Contact: Taylor Ewell, MS Taylor.Ewell@colostate.edu

Locations
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United States, Colorado
Colorado State University, Dept. of Health and Exercise Science Recruiting
Fort Collins, Colorado, United States, 80523-1582
Contact: Christopher Bell, PhD    970-491-7522    Christopher.Bell@colostate.edu   
Contact: Laurie M Biela, BS    970-491-2242    Laurie.Biela@colostate.edu   
Principal Investigator: Christopher Bell, PhD         
Principal Investigator: Tiffany Weir, PhD         
Sponsors and Collaborators
Christopher Bell
Caliper Foods
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Responsible Party: Christopher Bell, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT05285449    
Other Study ID Numbers: 2065
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants