Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota

NCT05285449 | Completed

• 1 other identifier: 2065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (23)

• 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

• 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

• Hepatic Insulin Extraction

  Measurements of C-Peptide concentration via ELISA Assays

  Compared to baseline after 4 weeks of the intervention

• Tissue oxygenation

  Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)

  Compared to baseline after 4 weeks of the intervention

• Reactive hyperemia

  Measurement of reactive hyperemia via doppler ultrasound

  Compared to baseline after 4 weeks of the intervention

• 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

• 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

• 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

• Abundant microbiota to markers in feces

  Assessed via Linear discriminant analysis Effect Size algorithm

  Compared to baseline after 4 weeks of the intervention

• Human Granulocyte Macrophage Colony-Stimulating Factor

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interferon gamma

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 1 beta

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 2

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 4

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 5

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 6

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 7

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 8

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 10

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 12 (p70)

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Interleukin 13

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• Tumor Necrosis Factor alpha

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

• High-sensitivity C-reactive protein

  Assessed via 13-plex human T-cell cytokine panel

  Compared to baseline after 4 weeks of the intervention

Study Arms (2)

Dietary Supplement: Cannabidiol (CBD) powder formulation

ACTIVE COMPARATOR

T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate

Dietary Supplement: Cannabidiol (CBD) powder formulation

Dietary Supplement: CBD matching Placebo

PLACEBO COMPARATOR

Matching Placebo

Dietary Supplement: Matching Placebo Cannabidiol (CBD) powder formulation

Interventions

Cannabidiol (CBD) powder formulation DIETARY_SUPPLEMENT

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

Also known as: T-P-S-10 Caliper powder

Dietary Supplement: Cannabidiol (CBD) powder formulation

Matching Placebo Cannabidiol (CBD) powder formulation DIETARY_SUPPLEMENT

Matching Placebo

Dietary Supplement: CBD matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,
• hydroxy-3-methylglutaryl coenzyme A reductase inhibitors,
• calcium channel blockers,
• antihistamines,

Sponsors & Collaborators

• Christopher Bell: lead
• Caliper Foods: collaborator

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-Blind random assignment to either placebo or active CBD (2 x 30 mg daily)

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: February 9, 2022
• Primary Completion: March 9, 2023
• Study Completion: May 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1)