The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes

NCT ID: NCT06324669

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-16

Study Completion Date

2025-01-26

Brief Summary

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Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised cross over trial counterbalanced for trial order
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Coded, known only to independent individual

Study Groups

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Ketone supplementation

100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com)

Group Type EXPERIMENTAL

Ketone supplement

Intervention Type DIETARY_SUPPLEMENT

100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Placebo

Placebo with stevia and bitter agent to flavour match

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Interventions

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Ketone supplement

100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Placebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Aged 41-70 years old
2. Body mass index 27-40 mg/m²
3. Type 2 diagnosis for more than 1 year
4. HbA1c \>6%

Exclusion Criteria

1. Currently following ketogenic diet
2. Use of insulin
3. HbA1c \>10%
4. Recent weight loss (\>5kg in 6 months)
5. Recent eGFR \<30mL/min
6. Heart failure
7. Substance abuse
8. Cancer
9. Myocardial infarction within 6 months
10. Pregnancy or consideration of
11. Use of antipsychotic drugs
Minimum Eligible Age

41 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis B Stephens, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

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Sport & Health Sciences University of Exeter

Exeter, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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4765060

Identifier Type: -

Identifier Source: org_study_id

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