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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05983562
• Other study ID #: RKT2D_concentrate
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brief 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

Inclusion Criteria:

• diagnosed with type 2 diabetes by a physician at least 1 year prior

• stable use of glucose-lowering medications for at least three months

• must be able to read and understand English in order to complete the study questionnaires

Exclusion Criteria:

• competitively trained endurance athlete

• actively attempting to gain or lose weight

• having a history of mental illness or existing neurological disease

• having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease

• are currently taking SGLT2 inhibitors or insulin

• are using more than 2 classes of glucose-lowering medication

• currently following a ketogenic diet or regularly taking ketone supplements

• unable to commit to a 90-day trial

• being unable to follow remote guidance by internet or smartphone

• currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Ketosis

Intervention

Dietary Supplement:
• Dietary Supplement: D-ß-hydroxybutyric acid with R-1,3-butanediol
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.

Other:
• Inert placebo
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A recruitment rate of at least 4 participants per month (which will ensure the study is fully enrolled within a 1-year timeline) will be acceptable.	Start of enrolment to completion of enrolment
Primary	To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed	= 67% of the drinks provided being consumed by participants as determined via self-report (i.e., an average of two out of three drinks per day being consumed) will be acceptable.	Across the 90-day intervention period (days 0 through 90)
Primary	To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study	= 30% of recruited participants dropping out of the study will be acceptable	Across the 90-day intervention period (days 0 through 90)
Secondary	Measures of glycemic control (HbA1c)	Glycemic control will be measured by assessing HbA1c in a clinical laboratory.	Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Measures of glycemic control (postprandial glucose area under the curve)	Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 2-hour postprandial hyperglycemia.	Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Secondary	Measures of glycemic control (average daily glucose)	Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the average daily glucose.	Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Secondary	Measures of glycemic control (glucose variability)	Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing glucose variability.	Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Secondary	Supplement acceptability	Supplement acceptability will be assessed via questionnaire.	Days 1, 45, and 90
Secondary	Gastrointestinal distress	Gastrointestinal distress will be assessed via questionnaire.	Days 1, 45, and 90
Secondary	Self-reported body weight	Self-reported body weight will be assessed by questionnaire.	Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Self-reported waist circumference	Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape).	ay 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Self-reported energy consumption	Self-reported energy consumption will be assessed via 24-hour dietary recalls.	Days 0 (pre-intervention/baseline), 45, and 90
Secondary	Levels of perceived hunger	Levels of perceived hunger will be assessed via questionnaire.	Days 0 (pre-intervention/baseline), 45, and 90
Secondary	High-sensitivity c-reactive protein	High-sensitivity c-reactive protein will be measured in a clinical laboratory.	Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Hematology panel	Hematology panel will be measured in a clinical laboratory.	Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Liver enzymes (ALT, AST)	Liver enzymes (ALT, AST) will be measured in a clinical laboratory.	Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)	Lipid panel will be measured in a clinical laboratory.	Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Secondary	Levels of physical activity	Theory of planned behaviour will be assessed via questionnaire.	Days 0 (pre-intervention/baseline) and 45
Secondary	Sleep quality	Sleep quality will be assessed via questionnaire.	Days 0 (pre-intervention/baseline), 45, and 90
Secondary	Cravings	Cravings will be assessed via questionnaire.	Days 0 (pre-intervention/baseline), 45, and 90
Secondary	Self-rated health	Self-rated health and its impacts on daily life will be assessed via questionnaire.	Days 0 (pre-intervention/baseline), 45, and 90
Secondary	Self-reported blood pressure (systolic and diastolic)	Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).	Days 0 (pre-intervention/baseline), 45, and 90
Secondary	Theory of planned behaviour	Theory of planned behaviour will be assessed via questionnaire.	Days 0 (pre-intervention/baseline) and 45
Secondary	Overall acceptability	Will be assessed via an open ended questionnaire either at completion time or in case of withdrawal	Day 90 or in case of withdrawal