Markers of Appetite Regulation During Exogenous Ketosis

NCT04156477 | Unknown DMC

• 1 other identifier: 121953
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Satiety, desire to eat, and perceived hunger sensation

  5 hours

• Glucose concentration

  5 hours

• Insulin concentration

  5 hours

• Free fatty acids concentration

  5 hours

Study Arms (3)

Ketone ester

EXPERIMENTAL

Intake of a ketogenic drink.

Dietary Supplement: Ketone ester

Isocaloric and -volumetric glucose drink

ACTIVE COMPARATOR

Intake of a taste matched glucogenic drink.

Dietary Supplement: Glucose

Isovolumetric tap water drink

PLACEBO COMPARATOR

Intake of a taste matched tap water drink.

Dietary Supplement: Tap water

Interventions

Ketone ester DIETARY_SUPPLEMENT

Intake of weight adjusted drink of a ketone ester

Ketone ester

Glucose DIETARY_SUPPLEMENT

Isocaloric and - volumetric taste adjusted drink

Isocaloric and -volumetric glucose drink

Tap water DIETARY_SUPPLEMENT

Isovolumetric taste adjusted tap water (placebo)

Isovolumetric tap water drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 18-65 years
• BMI 20-35 kg/m2
• Expected ease of catheter insertion
• Oral and written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Related Publications (4)

• 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.

  PMID: 20416348 BACKGROUND

• 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.

  PMID: 29163194 BACKGROUND

• Myette-Cote E, 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.

  PMID: 29446830 BACKGROUND

• Svart M, Rittig N, Luong TV, Gopalasingam N, Vestergaard ET, Gormsen L, Sondergaard E, Thomsen HH, Gravholt CH. Three Weeks on a Ketogenic Diet Reduces Free Testosterone and Free Estradiol in Middle-Aged Obese Men and Women. J Nutr Metab. 2024 Aug 6;2024:9301369. doi: 10.1155/2024/9301369. eCollection 2024.

  PMID: 39139216 DERIVED

MeSH Terms

Conditions

Ketosis

Interventions

formic acid 4-(3-oxobutyl)phenyl ester; Glucose

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Henrik H Thomsen, M.D., PhD

  Viborg Region Hospital, Central Jutland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a experimental, randomized, single-center cross-over study.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 7, 2019
• Study Start: October 24, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)