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Ketone Concentrate Supplement Drink for Type 2 Diabetes

N/A

Waitlist Available

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)

Awards & highlights

Study Summary

This trial will look at if drinking ketone supplements can lower blood sugar levels in people with type 2 diabetes over 3 months.

Who is the study for?

Adults with type 2 diabetes who have been on stable glucose-lowering medications for at least three months, can read and understand English, and were diagnosed over a year ago. Not eligible if they're endurance athletes, unable to commit to 90 days, can't follow remote guidance, changing weight actively, or have certain medical conditions or are taking specific medications.Check my eligibility

What is being tested?

The trial is testing if adults with type 2 diabetes can feasibly consume ketone supplement drinks daily for 90 days versus a placebo. The goal is to see if these supplements improve blood sugar control without dietary changes by comparing two groups: one drinking the ketones and the other a non-active drink.See study design

What are the potential side effects?

Potential side effects of the ketone supplements may include digestive discomfort such as nausea or stomach upset due to their novel introduction into the diet. Long-term effects are being studied; therefore participants will be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of enrolment to completion of enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of enrolment to completion of enrolment

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of enrolment to completion of enrolment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial

To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed

To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study

Secondary outcome measures

Cravings

Gastrointestinal distress

Hematology panel

+18 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: Exogenous Ketone SupplementExperimental Treatment1 Intervention

Participants will be instructed to consume a total of 177 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 59 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days.

Group II: Placebo Comparator: Inert placeboPlacebo Group1 Intervention

Participants will be instructed to consume an equivalent volume (177 mL) of taste- and volume-matched placebo per day (3 doses at 59 mL) for 90 days.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,996 Total Patients Enrolled

Media Library

D-β-hydroxybutyric acid with R-1,3-butanediol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05983562 — N/A

Type 2 Diabetes Research Study Groups: Experimental: Exogenous Ketone Supplement, Placebo Comparator: Inert placebo

Type 2 Diabetes Clinical Trial 2023: D-β-hydroxybutyric acid with R-1,3-butanediol Highlights & Side Effects. Trial Name: NCT05983562 — N/A

D-β-hydroxybutyric acid with R-1,3-butanediol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05983562 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation permit individuals over eighty-five years of age to participate?

"This particular clinical trial is open only to patients aged between 30 and 69. In contrast, there are 193 trials available for those under 18 years of age and 1137 studies that cater to individuals over 65."

Answered by AI

How many subjects are actively enrolled in this clinical investigation?

"Affirmative. Clinicaltrials.gov currently states that this clinical trial is seeking participants, having first been posted on June 26th 2023 and updated most recently on August 1st of the same year. The study seeks to recruit a total of 20 patients from one medical centre."

Answered by AI

Is there an opportunity for me to partake in this research?

"The clinical trial is accepting 20 candidates that meet the requirements of having type 2 diabetes and being between 30 to 69 years old."

Answered by AI

What is the ultimate aim of this research?

"The primary evaluation criteria of this trial, gauged from the start to completion of enrolment, will be ascertaining patients' compliance via self-reported volume of ketone supplement drink consumed. Additional secondary outcomes include assessments of glycemic control through postprandial glucose area under the curve measurements by FreeStyle Libre 2 (Abbott), average daily glucose levels monitored with FreeStyle Libre 2 (Abbott) and quantified through individualized glucose variability readings."

Answered by AI

Are there still openings for volunteers to participate in this experiment?

"Affirmative. On clinicaltrials.gov, it is evident that this study is currently seeking participants - which began on June 26th 2023 and was most recently revised on August 1st 2023. The trial aims to enroll twenty patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes

Jonathan Little 2023. "Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05983562.