Clinical trial NCT05983562: Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes
Official title: Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hyperglycemia
Ketosis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Start of enrolment to completion of enrolment
measure: To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed
timeFrame: Across the 90-day intervention period (days 0 through 90)
measure: To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study
timeFrame: Across the 90-day intervention period (days 0 through 90)
Secondary outcomes:
measure: Measures of glycemic control (HbA1c)
timeFrame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Measures of glycemic control (postprandial glucose area under the curve)
timeFrame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
measure: Measures of glycemic control (average daily glucose)
timeFrame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
measure: Measures of glycemic control (glucose variability)
timeFrame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
measure: Supplement acceptability
timeFrame: Days 1, 45, and 90
measure: Gastrointestinal distress
timeFrame: Days 1, 45, and 90
measure: Self-reported body weight
timeFrame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Self-reported waist circumference
timeFrame: ay 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Self-reported energy consumption
timeFrame: Days 0 (pre-intervention/baseline), 45, and 90
measure: Levels of perceived hunger
timeFrame: Days 0 (pre-intervention/baseline), 45, and 90
measure: High-sensitivity c-reactive protein
timeFrame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Hematology panel
timeFrame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Liver enzymes (ALT, AST)
timeFrame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)
timeFrame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
measure: Levels of physical activity
timeFrame: Days 0 (pre-intervention/baseline) and 45
measure: Sleep quality
timeFrame: Days 0 (pre-intervention/baseline), 45, and 90
measure: Cravings
timeFrame: Days 0 (pre-intervention/baseline), 45, and 90
measure: Self-rated health
timeFrame: Days 0 (pre-intervention/baseline), 45, and 90
measure: Self-reported blood pressure (systolic and diastolic)
timeFrame: Days 0 (pre-intervention/baseline), 45, and 90
measure: Theory of planned behaviour
timeFrame: Days 0 (pre-intervention/baseline) and 45
measure: Overall acceptability
timeFrame: Day 90 or in case of withdrawal
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References: