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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04156477
Other study ID # 121953
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 24, 2019
Est. completion date December 2019

Study information

Verified date October 2019
Source Central Jutland Regional Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.


Description:

All subjects are, in random order, tested on three separate occasions with intake of weight adjusted and taste matched drink of i) a ketone ester, and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink.

Subjects are studied for five hours with baseline and blood sampling on multiple occasions. A satiety questionaire are included.

Subjects are recruited through notice on website for this purpose. Sample size calculations were performed prior to inclusion (n=10). According to protocolized statistical plan, missing data will not be replaced and no imputation will occur. Data will be analyzed by applying a repeated measurements multilevel model with intervention, time and their interactions as categorical factors. Effects size are adjusted for small sample size.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Males aged 18-65 years

- BMI 20-35 kg/m2

- Expected ease of catheter insertion

- Oral and written informed consent

Exclusion Criteria:

- Inability to fully understand the consent including consent forms

- Inability to cooperate to the trial

- Any electrolyte disorders, kidney disease or otherwise compromised renal function including excess risk hereof, e.g. hypertension, albuminuria, autoimmune disease, family history of kidney disease

- Any liver or bile disease including excess risk hereof, e.g. hepatotoxic drugs, alcohol abuse disorder, gallstones, pancreatitis, autoimmune disease, family history of liver disease

- Diabetes mellitus or any metabolic and/or hormonal disease including diagnosed/undiagnosed reactive hypoglycemia or similar disorders. This includes treatment with drugs, dietary supplement with inference on key metabolic or hormonal markers, e.g. insulin, glukagon, lipids, and GLP-1

- Any use of illegal or otherwise use of medicinal products without prescription

- Anemia or other know disease of the hematopoietic system

- Previous bariatric surgery

- Previous myocardial infarction or uncontrolled myocardial ischemia

- Recent intended/unintended weight loss

- Allergies to catheters or adhesives

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ketone ester
Intake of weight adjusted drink of a ketone ester
Glucose
Isocaloric and - volumetric taste adjusted drink
Tap water
Isovolumetric taste adjusted tap water (placebo)

Locations

Country Name City State
Denmark Regionshospitalet Viborg Viborg

Sponsors (1)

Lead Sponsor Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Laeger T, Metges CC, Kuhla B. Role of beta-hydroxybutyric acid in the central regulation of energy balance. Appetite. 2010 Jun;54(3):450-5. doi: 10.1016/j.appet.2010.04.005. Epub 2010 Apr 21. Review. — View Citation

Myette-Côté É, Neudorf H, Rafiei H, Clarke K, Little JP. Prior ingestion of exogenous ketone monoester attenuates the glycaemic response to an oral glucose tolerance test in healthy young individuals. J Physiol. 2018 Apr 15;596(8):1385-1395. doi: 10.1113/JP275709. Epub 2018 Mar 2. — View Citation

Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary GLP-1 concentration Development of GLP-1 concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. 5 hours
Primary Acyl ghrelin concentration Development of acyl ghrelin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. 5 hours
Secondary Satiety, desire to eat, and perceived hunger sensation Scores of satiety, desire to eat, and perceived hunger sensation during intervention all measured on a scale from 1-100 where 1 is the lowest score and 100 the highest. 5 hours
Secondary Glucose concentration Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. 5 hours
Secondary Insulin concentration Development of insulin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. 5 hours
Secondary Free fatty acids concentration Development of free fatty acids concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. 5 hours
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