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

U

University of Exeter

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Dietary Supplement: Ketone supplement
Dietary Supplement: Placebo supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT06324669
4765060

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

41 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups, including a placebo group

Ketone supplementation
Experimental group
Description:
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)
Treatment:
Dietary Supplement: Ketone supplement
Placebo
Placebo Comparator group
Description:
Placebo with stevia and bitter agent to flavour match
Treatment:
Dietary Supplement: Placebo supplement

Trial contacts and locations

1

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Central trial contact

Francis B Stephens, PhD

Data sourced from clinicaltrials.gov

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