D-β-hydroxybutyric acid with R-1,3-butanediol for Ketosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of British Columbia, Kelowna, Canada
Ketosis+3 More
D-β-hydroxybutyric acid with R-1,3-butanediol - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function. Recently, ketone supplements have been developed that can be consumed as a drink. These supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. Drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function. To find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.

Eligible Conditions

  • Ketosis
  • Diabetes
  • Hyperglycemia

Treatment Effectiveness

Study Objectives

3 Primary · 16 Secondary · Reporting Duration: Days 1 through 14 (first 2 weeks) and days 77 through 90 (last 2 weeks)

Day 0
Intervention acceptability
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
Viability of methods
Day 90
Hematology panel
High-sensitivity c-reactive protein
Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)
Liver enzymes (ALT, AST)
Measures of glycemic control (HbA1c)
Self-reported body weight
Self-reported waist circumference
Day 0
Theory of planned behaviour
Day 0
Levels of perceived hunger
Levels of physical activity
Self-reported energy consumption
Week 2
Measures of glycemic control (average daily glucose)
Measures of glycemic control (glucose variability)
Measures of glycemic control (postprandial glucose area under the curve)
Day 1
Gastrointestinal distress
Supplement acceptability
Start of enrolment to completion of enrolment
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

Trial Safety

Trial Design

2 Treatment Groups

Exogenous Ketone Supplement
1 of 2
Inert placebo
1 of 2
Experimental Treatment
Non-Treatment Group

36 Total Participants · 2 Treatment Groups

Primary Treatment: D-β-hydroxybutyric acid with R-1,3-butanediol · Has Placebo Group · N/A

Exogenous Ketone Supplement
DietarySupplement
Experimental Group · 1 Intervention: D-β-hydroxybutyric acid with R-1,3-butanediol · Intervention Types: DietarySupplement
Inert placebo
Other
PlaceboComparator Group · 1 Intervention: Inert placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 1 through 14 (first 2 weeks) and days 77 through 90 (last 2 weeks)
Closest Location: University of British Columbia · Kelowna, Canada
Photo of british columbia 1Photo of british columbia 2Photo of british columbia 3
2004First Recorded Clinical Trial
1 TrialsResearching Ketosis
201 CompletedClinical Trials

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,295 Previous Clinical Trials
1,270,971 Total Patients Enrolled
3 Trials studying Ketosis
42 Patients Enrolled for Ketosis
Jonathan Little, PhDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
185 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be able to read and understand English in order to complete the study questionnaires.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.