Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

Diabetes Clinical Trial

Official title:

Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05285449
• Other study ID #: 2065
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• Cannabidiol (CBD) powder formulation
30 mg CBD in the form of 300 mg of 10% CBD isolate
• Matching Placebo Cannabidiol (CBD) powder formulation
Matching Placebo

Locations

Country	Name	City	State
United States	Colorado State University, Dept. of Health and Exercise Science	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Christopher Bell	Caliper Foods

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating blood glucose	Measurements of circulating blood glucose during an Oral Glucose Tolerance Tests via a blood analyzer	Compared to baseline after 4 weeks of the intervention
Primary	Circulating blood insulin	Measurements of circulating insulin during an Oral Glucose Tolerance Tests via a blood analyzer	Compared to baseline after 4 weeks of the intervention
Primary	Hepatic Insulin Extraction	Measurements of C-Peptide concentration via ELISA Assays	Compared to baseline after 4 weeks of the intervention
Primary	Tissue oxygenation	Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)	Compared to baseline after 4 weeks of the intervention
Primary	Reactive hyperemia	Measurement of reactive hyperemia via doppler ultrasound	Compared to baseline after 4 weeks of the intervention
Primary	Shannon and Faith's microbiota diversity scores in feces	Assessed via 16s ribosomal ribonucleic acid microbial profiling	Compared to baseline after 4 weeks of the intervention
Primary	B-diversity scores for all fecal samples to assess clustering	Assessed via 16s ribosomal ribonucleic acid microbial profiling	Compared to baseline after 4 weeks of the intervention
Primary	Differentially abundant microbiota in feces of collected during treatment	Assessed via 16s ribosomal ribonucleic acid microbial profiling	Compared to baseline after 4 weeks of the intervention
Primary	Abundant microbiota to markers in feces	Assessed via Linear discriminant analysis Effect Size algorithm	Compared to baseline after 4 weeks of the intervention
Primary	Human Granulocyte Macrophage Colony-Stimulating Factor	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interferon gamma	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 1 beta	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 2	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 4	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 5	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 6	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 7	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 8	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 10	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 12 (p70)	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Interleukin 13	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	Tumor Necrosis Factor alpha	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention
Primary	High-sensitivity C-reactive protein	Assessed via 13-plex human T-cell cytokine panel	Compared to baseline after 4 weeks of the intervention