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

NCT05983562 | Active Not Recruiting

• 1 other identifier: RKT2D_concentrate
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Ketosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (21)

• Measures of glycemic control (HbA1c)

  Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)

• Measures of glycemic control (postprandial glucose area under the curve)

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

• Measures of glycemic control (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)

• Measures of glycemic control (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)

• Supplement acceptability

  Days 1, 45, and 90

Study Arms (2)

Experimental: Exogenous Ketone Supplement

EXPERIMENTAL

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.

Dietary Supplement: Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol

Placebo Comparator: Inert placebo

PLACEBO COMPARATOR

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.

Other: Inert placebo

Interventions

Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol DIETARY_SUPPLEMENT

Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.

Experimental: Exogenous Ketone Supplement

Inert placebo OTHER

Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively

Placebo Comparator: Inert placebo

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Ketosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acidosis; Acid-Base Imbalance

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: August 9, 2023
• Study Start: June 26, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The de-identified data and associated documents will be made available to researchers upon reasonable request for the duration that is required by the researchers.
• Access Criteria: Researchers from accredited institutions will be granted access to the de-identified data and associated documents provided they can show that it will be used for a research-related purpose (e.g., meta-analysis).

Locations

CA (1)