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Completed

NCT Number: NCT05285449

Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol (CBD) powder formulation

Dietary Supplement

30 mg CBD in the form of 300 mg of 10% CBD isolate

Other names: T-P-S-10 Caliper powder

Matching Placebo Cannabidiol (CBD) powder formulation

Dietary Supplement

Matching Placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Christopher Bell

Other

Collaborators

  • Caliper Foods

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 17, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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