Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Interferon gamma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The CBD and placebo formulations are prepared, bottled, and coded by Caliper Foods. The participants will receive a coded bottle to consume of the different formulations of CBD and placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •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.
结局指标
主要结局
Interferon gamma
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 4
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 7
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Circulating blood glucose
时间窗: Compared to baseline after 4 weeks of the intervention
Measurements of circulating blood glucose during an Oral Glucose Tolerance Tests via a blood analyzer
Circulating blood insulin
时间窗: Compared to baseline after 4 weeks of the intervention
Measurements of circulating insulin during an Oral Glucose Tolerance Tests via a blood analyzer
Hepatic Insulin Extraction
时间窗: Compared to baseline after 4 weeks of the intervention
Measurements of C-Peptide concentration via ELISA Assays
Reactive hyperemia
时间窗: Compared to baseline after 4 weeks of the intervention
Measurement of reactive hyperemia via doppler ultrasound
Differentially abundant microbiota in feces of collected during treatment
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Shannon and Faith's microbiota diversity scores in feces
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Human Granulocyte Macrophage Colony-Stimulating Factor
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Abundant microbiota to markers in feces
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via Linear discriminant analysis Effect Size algorithm
Interleukin 1 beta
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 8
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 13
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 10
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 12 (p70)
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Tumor Necrosis Factor alpha
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
High-sensitivity C-reactive protein
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
B-diversity scores for all fecal samples to assess clustering
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Tissue oxygenation
时间窗: Compared to baseline after 4 weeks of the intervention
Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)
Interleukin 2
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 5
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 6
时间窗: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
次要结局
未报告次要终点
研究者
Christopher Bell
Associate Professor
Colorado State University