Clinical Trials Directory

Trials / Completed

CompletedNCT05285449

Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Christopher Bell · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCannabidiol (CBD) powder formulation30 mg CBD in the form of 300 mg of 10% CBD isolate
DIETARY_SUPPLEMENTMatching Placebo Cannabidiol (CBD) powder formulationMatching Placebo

Timeline

Start date
2022-02-09
Primary completion
2023-03-09
Completion
2024-05-31
First posted
2022-03-17
Last updated
2024-07-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05285449. Inclusion in this directory is not an endorsement.