Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

NCT ID: NCT05285449

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2024-05-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Cannabidiol (CBD) powder formulation

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary Supplement: CBD matching Placebo

Matching Placebo

Group Type: PLACEBO_COMPARATOR

Matching Placebo Cannabidiol (CBD) powder formulation

Intervention Type: DIETARY_SUPPLEMENT

Matching Placebo

Interventions

Cannabidiol (CBD) powder formulation

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

Intervention Type: DIETARY_SUPPLEMENT

Matching Placebo Cannabidiol (CBD) powder formulation

Matching Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

T-P-S-10 Caliper powder

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Caliper Foods

UNKNOWN

Sponsor Role: collaborator

Christopher Bell

OTHER

Sponsor Role: lead

Responsible Party

Christopher Bell

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

2065

Identifier Type: -

Identifier Source: org_study_id