Clinical trial NCT05285449: Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
Official title: Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Caliper Foods
First posted: 2022-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind random assignment to either placebo or active CBD (2 x 30 mg daily)
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Circulating blood glucose
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Circulating blood insulin
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Hepatic Insulin Extraction
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Tissue oxygenation
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Reactive hyperemia
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Shannon and Faith's microbiota diversity scores in feces
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: B-diversity scores for all fecal samples to assess clustering
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Differentially abundant microbiota in feces of collected during treatment
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Abundant microbiota to markers in feces
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Human Granulocyte Macrophage Colony-Stimulating Factor
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interferon gamma
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 1 beta
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 2
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 4
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 5
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 6
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 7
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 8
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 10
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 12 (p70)
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Interleukin 13
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: Tumor Necrosis Factor alpha
timeFrame: Compared to baseline after 4 weeks of the intervention
measure: High-sensitivity C-reactive protein
timeFrame: Compared to baseline after 4 weeks of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University, Dept. of Health and Exercise Science
state: Colorado
Study officials:
References: