Trials / Unknown
UnknownNCT04156477
Markers of Appetite Regulation During Exogenous Ketosis
Markers of Appetite Regulation During Exogenous Ketosis - a Placebo Controlled Randomized Study of Appetite Regulatory and Metabolic Markers After Intake of a Keto- or Glucogenic Drink.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Central Jutland Regional Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Ketone ester | Intake of weight adjusted drink of a ketone ester |
| DIETARY_SUPPLEMENT | Glucose | Isocaloric and - volumetric taste adjusted drink |
| DIETARY_SUPPLEMENT | Tap water | Isovolumetric taste adjusted tap water (placebo) |
Timeline
- Start date
- 2019-10-24
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2019-11-07
- Last updated
- 2019-11-15
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04156477. Inclusion in this directory is not an endorsement.