NCT05263401

Brief Summary

The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks. The hypothesis is: 3-OHB as a pre-meal may:

  • Lower postprandial blood glucose and lipids.
  • Mediate release of intestinal hormones and affect gastric emptying.
  • Affect appetite and other subjective measures related to food intake. The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 4, 2023

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 14, 2021

Last Update Submit

April 3, 2023

Conditions

Type 2 DiabetesKetoses, Metabolic

Outcome Measures

Primary Outcomes (1)

  • Postprandial P-glucose

    Incremental area under the curve (iAUC) for P-glucose.

    3 hours

Secondary Outcomes (15)

  • Postprandial free fatty acids (FFA)

    3 hours

  • Differences in circulating concentrations of 3-hydroxybutyrate

    3,5 hours

  • Lipolysis rate

    3 hours

  • Glucose kinetics

    3 hours

  • Gastric emptying

    3 hours

  • +10 more secondary outcomes

Study Arms (3)

Ketone salt

EXPERIMENTAL

Na-D/L-3-hydroxybutyrate dissolved in tap water.

Dietary Supplement: 3-hydroxybutyrate

Ketone ester

EXPERIMENTAL

(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate

Dietary Supplement: 3-hydroxybutyrate

Placebo

PLACEBO COMPARATOR

Tap water

Dietary Supplement: 3-hydroxybutyrate

Interventions

3-hydroxybutyrateDIETARY_SUPPLEMENT

Orally administered pre-meal drinks.

Ketone esterKetone saltPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes diagnosis, metformin treated or dietary treated
  • HbA1C \< 80 mmol/mol
  • \< BMI \< 35
  • Written consent

You may not qualify if:

  • Severe comorbidity
  • Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
  • Specific diets, e.g. ketogenic diet
  • PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical research laboratory, Department of endocrinology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Bangshaab M, Bengtsen MB, Smedegaard S, Sondergaard E, Moller N, Svart MV, Rittig N. Ketone supplementation dose-dependently lowers postprandial blood glucose, lipid and ghrelin levels in individuals with type 2 diabetes: a randomised crossover study. Diabetologia. 2025 Nov 28. doi: 10.1007/s00125-025-06614-0. Online ahead of print.

    PMID: 41315088DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Ketosis

Interventions

3-Hydroxybutyric Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAcidosisAcid-Base Imbalance

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsKetone BodiesKetonesFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Niels Møller, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

March 2, 2022

Study Start

January 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 4, 2023

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)