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Markers of Appetite Regulation During Exogenous Ketosis (MARK)

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ClinicalTrials.gov Identifier: NCT04156477
Recruitment Status : Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Central Jutland Regional Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ketosis Dietary Supplement: Ketone ester Dietary Supplement: Glucose Dietary Supplement: Tap water Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a experimental, randomized, single-center cross-over study.
Masking: Single (Participant)
Masking 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 (HVMN Ketone, 38 Mason St, 3rd Floor, San Francisco, CA 94102, USA) and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink. Taste matching for the latter two are done by adding of a bitterness additive (Bitrex, Integriertes Trademarketing GmbH Herderstraße 16, 23564 Lübeck, Germany) with additional adding Stevia (Bodylab Stevia Drops; Bodylab,Plastvænget 3D, 9650 Hadsund, Denmark) for the tap water drink. Subjects will subsequently drink 50 mL of zero-calorie drink (Gatorade (Gatorade Company, Inc., Chicago, IL, USA) in order to eliminate any remaining flavour of the intervention drinks.
Primary Purpose: Basic Science
Official Title: 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.
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Ketone ester
Intake of a ketogenic drink.
Dietary Supplement: Ketone ester
Intake of weight adjusted drink of a ketone ester

Active Comparator: Isocaloric and -volumetric glucose drink
Intake of a taste matched glucogenic drink.
Dietary Supplement: Glucose
Isocaloric and - volumetric taste adjusted drink

Placebo Comparator: Isovolumetric tap water drink
Intake of a taste matched tap water drink.
Dietary Supplement: Tap water
Isovolumetric taste adjusted tap water (placebo)




Primary Outcome Measures :
  1. GLP-1 concentration [ Time Frame: 5 hours ]
    Development of GLP-1 concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.

  2. Acyl ghrelin concentration [ Time Frame: 5 hours ]
    Development of acyl ghrelin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.


Secondary Outcome Measures :
  1. Satiety, desire to eat, and perceived hunger sensation [ Time Frame: 5 hours ]
    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.

  2. Glucose concentration [ Time Frame: 5 hours ]
    Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.

  3. Insulin concentration [ Time Frame: 5 hours ]
    Development of insulin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.

  4. Free fatty acids concentration [ Time Frame: 5 hours ]
    Development of free fatty acids concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156477


Locations
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Denmark
Regionshospitalet Viborg
Viborg, Denmark, 8800
Sponsors and Collaborators
Central Jutland Regional Hospital
Investigators
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Principal Investigator: Henrik H Thomsen, M.D., PhD Viborg Region Hospital, Central Jutland

Publications:
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Responsible Party: Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT04156477     History of Changes
Other Study ID Numbers: 121953
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases